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The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.
The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept 8-weekly | Experimental | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. |
|
| Belatacept 4-weekly | Active Comparator | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug | Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline | The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m^2 indicates lower renal function. | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline | The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded. | 6 months post baseline, 12 months post baseline |
| Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline |
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Inclusion Criteria:
Adult (age ≥18 years currently),
First-time renal transplant recipients of either living donor or deceased donor,
Patients at low immunologic risk, defined as
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Idelberto Badell, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33583120 | Derived | Badell IR, Parsons RF, Karadkhele G, Cristea O, Mead S, Thomas S, Robertson JM, Kim GS, Hanfelt JJ, Pastan SO, Larsen CP. Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial. Am J Transplant. 2021 Sep;21(9):3066-3076. doi: 10.1111/ajt.16538. Epub 2021 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept 8-weekly | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
| FG001 | Belatacept 4-weekly | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only included participants that received intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept 8-weekly | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline | The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m^2 indicates lower renal function. | Posted | Mean | 95% Confidence Interval | ml/min/1.73m^2 | 12 months from baseline |
|
Up to 12 months post baseline
Adverse events were captured through active surveillance via open ended questions by the research coordinator at each study visit in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
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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 | Belatacept 8-weekly | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious Severe Adverse Events | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious Adverse Events | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Idelberto Badell | Emory University | 404-712-6562 | ibadell@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2018 | Sep 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
The number of subjects with Grade IIA and lower severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells. |
| 6 months post baseline, 12 months post baseline |
| Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline | The number of subjects with Grade IIB and higher severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells. | 6 months post baseline, 12 months post baseline |
| Number of Deaths at 6 Months and 12 Months Post Baseline | The total number of subject deaths at 12 months from baseline will be recorded. | 6 months post baseline, 12 months post baseline |
| Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline | The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded. | 6 months post baseline, 12 months from baseline |
| Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline | The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded. | 6 moths post baseline, 12 months post baseline |
| Number of Clinic Visits | The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded. | At 12 months from baseline |
| Number of Subjects Needing Hospitalizations | The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded | At 12 months from baseline |
| Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline | The number of subjects needing transplant biopsies at 12 months from baseline will be recorded. | 12 months post baseline |
| Cost Analysis | The mean total cost of infusions received by each subject and those associated with round trip travel to the Emory Transplant Center (ETC) will be estimated using the distance between the residential addresses of subjects and the ETC. | At 12 months from baseline |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 |
| Belatacept 4-weekly |
Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Belatacept 4-weekly |
Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. |
|
|
| Secondary | Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline | The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded. | Posted | Count of Participants | Participants | 6 months post baseline, 12 months post baseline |
|
|
|
| Secondary | Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline | The number of subjects with Grade IIA and lower severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells. | Posted | Count of Participants | Participants | 6 months post baseline, 12 months post baseline |
|
|
|
| Secondary | Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline | The number of subjects with Grade IIB and higher severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells. | Posted | Count of Participants | Participants | 6 months post baseline, 12 months post baseline |
|
|
|
| Secondary | Number of Deaths at 6 Months and 12 Months Post Baseline | The total number of subject deaths at 12 months from baseline will be recorded. | Posted | Count of Participants | Participants | 6 months post baseline, 12 months post baseline |
|
|
|
| Secondary | Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline | The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded. | Posted | Count of Participants | Participants | 6 months post baseline, 12 months from baseline |
|
|
|
| Secondary | Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline | The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded. | Posted | Count of Participants | Participants | 6 moths post baseline, 12 months post baseline |
|
|
|
| Secondary | Number of Clinic Visits | The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded. | Resources/tools not available for recording/tracking the data required to reliably report the outcome. | Posted | At 12 months from baseline |
|
|
| Secondary | Number of Subjects Needing Hospitalizations | The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded | Resources/tools not available for recording/tracking the data required to reliably report the outcome. | Posted | At 12 months from baseline |
|
|
| Secondary | Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline | The number of subjects needing transplant biopsies at 12 months from baseline will be recorded. | Posted | Count of Participants | Participants | 12 months post baseline |
|
|
|
| Secondary | Cost Analysis | The mean total cost of infusions received by each subject and those associated with round trip travel to the Emory Transplant Center (ETC) will be estimated using the distance between the residential addresses of subjects and the ETC. | Resources/tools not available for recording/tracking the data required to reliably report the outcome. | Posted | At 12 months from baseline |
|
|
| 0 |
| 77 |
| 9 |
| 81 |
| 23 |
| 81 |
| EG001 | Belatacept 4-weekly | Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. | 2 | 76 | 10 | 82 | 27 | 82 |
| Non Infectious severe Adverse Events | General disorders | Systematic Assessment |
|
| Non melanoma skin cancer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |