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Kidney transplantation is the best treatment for many patients with kidney failure. Sometimes a transplanted kidney is rejected by the patient's immune system. Many types of immune system cells, including B cells, are active in rejection. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab is a medication used to treat a disease called lupus. Belimumab slows development of antibody-producing B cells. This study will test whether belimumab works on parts of the immune system that cause rejection. Twenty to thirty adults getting a kidney transplant will be in this study. Like flipping a coin, a computer will randomly assign half to be given belimumab and half to be given placebo (a fake medicine). Patients and doctors will not know which medicine was assigned until the study is over. A total of 7 doses of study medicine will be given through a vein. One dose will be given during transplant surgery, and the other 6 will be given 2, 4, 8, 12, 16 and 20 weeks after transplant surgery. Usual transplant medicines will also be given. After all of the doses have been given, patients will be watched and tested at 24, 36, and 52 weeks after the transplant surgery. Blood samples will be tested to see what study medicines do to the immune system in transplant patients. If patients get a kidney biopsy, the samples will be tested to see if belimumab had any effect. Patients will be asked many questions to see if they are having any side effects. The study will be done at Addenbrooke's Hospital in Cambridge and Guys &St Thomas Hospital in London, United Kingdom. A pharmaceutical company, GlaxoSmithKline, is funding the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab 10 mg | Experimental | Subjects will receive belimumab 10 mg/ Kilogram (kg) infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care. |
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| Placebo | Placebo Comparator | Subjects will receive placebo infusion on Days 0, 14, 28 and every 4 weeks thereafter for a total of 7 infusions. The last dose of investigational product will be administered at the Week 20 visit; In addition to investigational product, all subjects will receive standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Drug | Belimumab (10 mg/kg) will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in naïve B Cells From Baseline to Week 24 | Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. | Baseline and Week 24 |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths. | Up to 1 year |
| Number of Incidence of All Infections and Serious Infections | All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52 | Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0QQ | United Kingdom | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29910042 | Derived | Banham GD, Flint SM, Torpey N, Lyons PA, Shanahan DN, Gibson A, Watson CJE, O'Sullivan AM, Chadwick JA, Foster KE, Jones RB, Devey LR, Richards A, Erwig LP, Savage CO, Smith KGC, Henderson RB, Clatworthy MR. Belimumab in kidney transplantation: an experimental medicine, randomised, placebo-controlled phase 2 trial. Lancet. 2018 Jun 30;391(10140):2619-2630. doi: 10.1016/S0140-6736(18)30984-X. Epub 2018 Jun 14. |
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Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.
A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| FG001 | Belimumab 10mg/kg | Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in naïve B Cells From Baseline to Week 24 | Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. | Modified Intent to treat (MITT) Population | Posted | Least Squares Mean | Standard Error | cells/mm^3 | Baseline and Week 24 |
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks).
On-treatment SAEs and non-serious AEs are reported for MITT Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C511911 | belimumab |
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| Placebo | Drug | Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2) |
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| Up to 1 year |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 | Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52 | Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52 | Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 | Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 | Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 | Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 | Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52 | Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52 | Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52 | Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52 | Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52 | Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52 | Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 | Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 | Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 | Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52 | Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 | Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Week 24 and Week 52 |
| Baseline, Week 24 and Week 52 |
| Activated Memory B Cells Count at Week 24 and Week 52 | Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Activated Memory B Cells Percentage at Week 24 and Week 52 | Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Transitional B Cells Count at Week 24 and Week 52 | Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Transitional B Cells Percentage at Week 24 and Week 52 | Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Activated T Cell Count at Week 24 and Week 52 | A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Activated T Cell Percentage at Week 24 and Week 52 | Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Regulatory T Cell Count at Week 24 and Week 52 | Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Regulatory T Cell (%CD4) at Week 24 and Week 52 | Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52 | Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52 | The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Mean Serum Creatinine at Week 24 and Week 52 | Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Week 24 and Week 52 |
| Mean eGFR at Week 24 and Week 52 | The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles). | Week 24 and Week 52 |
| Mean Prednisolone Use at Week 24 | Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles). | Week 24 |
| London |
| SE1 9RT |
| United Kingdom |
| BG001 |
| Belimumab 10mg/kg |
Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| ID |
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| Title |
|---|
| Description |
|---|
| OG000 | Placebo | Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
| OG001 | Belimumab 10mg/kg | Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. |
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| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths. | mITT Population | Posted | Number | Participants | Up to 1 year |
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| Primary | Number of Incidence of All Infections and Serious Infections | All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection. | mITT Population | Posted | Number | Infections | Up to 1 year |
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| Primary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 | Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52 | Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Beats per minute (BPM) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52 | Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Degree Centigrade | Baseline, Week 24 and Week 52 |
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| Primary | Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 | Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Number | Participants | Week 24 and Week 52 |
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| Primary | Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 | Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Number | Participants | Week 24 and Week 52 |
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| Primary | Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 | Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Number | Participants | Week 24 and Week 52 |
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| Primary | Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 | Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Gills/Liter (GI/L) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52 | Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Grams per Liter (G/L) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52 | Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Percentage of blood | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52 | Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Picogram (pg) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52 | Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Femtoliter (FL) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52 | Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Tera (TI)/L | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52 | Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | G/L | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 | Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | International Unit (IU)/L | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 | Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Micromole per Liter (umol/L) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 | Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | Millimole (MMOL)/L | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52 | Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | milliliter (mL)/Minute (min) | Baseline, Week 24 and Week 52 |
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| Primary | Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 | Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Mean | Standard Deviation | G/L | Baseline, Week 24 and Week 52 |
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| Secondary | Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52 | Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method. | mITT Population | Posted | Median | Full Range | Percent change | Baseline, Week 24 and Week 52 |
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| Secondary | Activated Memory B Cells Count at Week 24 and Week 52 | Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | cells/mL | Week 24 and Week 52 |
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| Secondary | Activated Memory B Cells Percentage at Week 24 and Week 52 | Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | Percentage of activated memory B cells | Week 24 and Week 52 |
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| Secondary | Transitional B Cells Count at Week 24 and Week 52 | Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | cells/mL | Week 24 and Week 52 |
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| Secondary | Transitional B Cells Percentage at Week 24 and Week 52 | Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | Percentage of transitional B cells | Week 24 and Week 52 |
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| Secondary | Activated T Cell Count at Week 24 and Week 52 | A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | cells/mL | Week 24 and Week 52 |
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| Secondary | Activated T Cell Percentage at Week 24 and Week 52 | Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | Percentage of activated T cell | Week 24 and Week 52 |
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| Secondary | Regulatory T Cell Count at Week 24 and Week 52 | Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | cells/mL | Week 24 and Week 52 |
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| Secondary | Regulatory T Cell (%CD4) at Week 24 and Week 52 | Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | Percentage of Regulatory T cell | Week 24 and Week 52 |
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| Secondary | Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52 | Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | Ratio | Week 24 and Week 52 |
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| Secondary | Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52 | The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population. Participants analyzed had at least one biopsy. | Posted | Number | Proportion of participants | Week 24 and Week 52 |
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| Secondary | Mean Serum Creatinine at Week 24 and Week 52 | Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | micromole/L | Week 24 and Week 52 |
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| Secondary | Mean eGFR at Week 24 and Week 52 | The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | mL/minute/1.73 square meter (m^2) | Week 24 and Week 52 |
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| Secondary | Mean Prednisolone Use at Week 24 | Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles). | mITT Population | Posted | Least Squares Mean | Standard Error | mg/day | Week 24 |
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| 7 |
| 13 |
| 9 |
| 13 |
| EG001 | Belimumab 10mg/kg | Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study. | 5 | 12 | 9 | 12 |
| Alanine aminotransferase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Glomerulonephritis | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
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| Lymphocele | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Renal cyst infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Polyomavirus test positive | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cytomegalovirus test positive | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Epstein-Barr virus test positive | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Polycythaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Polyomavirus-associated nephropathy | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Renal cyst infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Ulcerative gastritis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Urinary tract infection enterococcal | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Vasculitic rash | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 18.1 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| OT SAEs |
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| PT SAEs |
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| Malignant neoplasms |
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| Post-Infusion Systemic Reactions |
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| All Infections |
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| Depression/suicide/self-injury |
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| Deaths |
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| All Opportunistic Infections |
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| Serious Opportunistic Infections |
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| All Herpes Zoster |
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| Serious Herpes Zoster |
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| Sepsis |
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| Serious Sepsis |
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| SBP Week 24; n=9, 7 |
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| SBP Week 52; n=11, 10 |
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| DBP, > NR, Week 52; n=11, 10 |
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| DBP, < NR, Week 52; n=11, 10 |
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| SBP, > NR, Week 24; n=9, 7 |
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| SBP, < NR, Week 24; n=9, 7 |
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| SBP, > NR, Week 52; n=11, 10 |
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| SBP, < NR, Week 52; n=11, 10 |
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| > NR Week 52; n=11, 9 |
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| < NR Week 52; n=11, 9 |
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| > NR Week 52; n=11, 10 |
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| < NR Week 52; n=11, 10 |
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| E Week 24; n=9, 6 |
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| E Week 52; n=10, 10 |
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| L Week 24; n=9, 6 |
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| L Week 52; n=10, 10 |
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| M Week 24; n=9, 6 |
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| M Week 52; n=10, 10 |
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| TN Week 24; n=9, 6 |
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| TN Week 52; n=10, 10 |
|
| PC Week 24; n=9, 6 |
|
| PC Week 52; n=11, 10 |
|
| WBC Week 24; n=9, 6 |
|
| WBC Week 52; n=11, 10 |
|
| ALT Week 24; n=9, 7 |
|
| ALT Week 52; n=10, 10 |
|
| AST Week 24; n=6, 3 |
|
| AST Week 52; n=7, 4 |
|
| TB Week 24; n=9, 7 |
|
| TB Week 52; n=10, 10 |
|
| C Week 24; n=9, 7 |
|
| C Week 52; n=10, 10 |
|
| CO2/Bicar Week 24; n=7, 6 |
|
| CO2/Bicar Week 52; n=8, 9 |
|
| Gl Week 24; n=5, 5 |
|
| Gl Week 52; n=5, 8 |
|
| K Week 24; n=9, 7 |
|
| K Week 52; n=10, 10 |
|
| Na Week 24; n=9, 7 |
|
| Na Week 52; n=10, 10 |
|
| PhI Week 24; n=8, 7 |
|
| PhI Week 52; n=9, 9 |
|
| U/BUN Week 24; n=9, 6 |
|
| U/BUN Week 52; n=10, 9 |
|
| IgG Week 24; n=6, 6 |
|
| IgG Week 52; n=10, 9 |
|
| IgM Week 24; n=2, 3 |
|
| IgM Week 52; n=2, 3 |
|
| Median Difference (Final Values) |
| -33.06 |
| 2-Sided |
| 95 |
| -169.84 |
| 25.00 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -13128.35 |
| Standard Error of the Mean |
| 24165.18 |
| 2-Sided |
| 95 |
| -61868.9 |
| 35612.2 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| 6.8 |
| Standard Error of the Mean |
| 7.68 |
| 2-Sided |
| 95 |
| -8.6 |
| 22.2 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -458 |
| Standard Error of the Mean |
| 4501.8 |
| 2-Sided |
| 95 |
| -9487 |
| 8572 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| 0.79 |
| Standard Error of the Mean |
| 1.017 |
| 2-Sided |
| 95 |
| -1.24 |
| 2.82 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -46955.3 |
| Standard Error of the Mean |
| 32594.81 |
| 2-Sided |
| 95 |
| -113218.9 |
| 19308.3 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.4 |
| Standard Error of the Mean |
| 3.35 |
| 2-Sided |
| 95 |
| -7.2 |
| 6.3 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -5618.9 |
| Standard Error of the Mean |
| 12153.03 |
| 2-Sided |
| 95 |
| -29994.8 |
| 18757.0 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -0.6 |
| Standard Error of the Mean |
| 1.45 |
| 2-Sided |
| 95 |
| -3.5 |
| 2.3 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -1.01 |
| Standard Error of the Mean |
| 1.329 |
| 2-Sided |
| 95 |
| -3.68 |
| 1.67 |
Week 52 comparison |
| Superiority or Other |
| Difference in Proportion |
| -0.267 |
| 2-Sided |
| 95 |
| -0.838 |
| 0.305 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -12.9 |
| Standard Error of the Mean |
| 47.52 |
| 2-Sided |
| 95 |
| -107.1 |
| 81.4 |
Week 52 comparison |
| Superiority or Other |
| Mean Difference (Final Values) |
| -2.70 |
| Standard Error of the Mean |
| 8.315 |
| 2-Sided |
| 95 |
| -19.11 |
| 13.72 |
Week 52 comparison |
| Superiority or Other |