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This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.
The participant sampling method used in the Orange study was consecutive sampling, a non-probability sampling method where each participant meeting the study's inclusion and exclusion criteria is selected and enrolled in the study until the pre-set sample size is achieved.
Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate mofetil immunosuppressive combination therapy in routine clinical practice, were selected in a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion criteria until 128 participants were recruited to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Transplant Participants | Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Creatinine Clearance at 1 Month After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | Month 1 |
| Creatinine Clearance at Month 6 After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | Month 6 |
| Creatinine Clearance at Month 12 After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | Month 12 |
| Glomerular Filtration Rate (GFR) at Month 1 After Transplantation | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure. | Month 1 |
| GFR at Month 6 After Transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose of Mycophenolate Mofetil | Baseline, Months 1, 6, and 12 | |
| Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil | Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1082 | Hungary | ||||
If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Transplant Participants | Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Immunosuppressive Therapy | Drug | Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician. |
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GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
| Month 6 |
| GFR at Month 12 After Transplantation | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure. | Month 12 |
| Baseline, Months 1, 6, and 12 |
| Percentage of Participants With Acute Rejection | Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported. | Baseline to Month 1, Months 2 to 6, Months 7 to 12 |
| Percentage of Participants With Graft Survival | Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation. | Months 1, 6, and 12 |
| Pécs |
| 7624 |
| Hungary |
| Intent-to-treat (ITT) Population |
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| COMPLETED |
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| NOT COMPLETED |
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ITT population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy and had no major protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Transplant Participants | Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen. |
| 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 | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Creatinine Clearance at 1 Month After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 1 |
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| Primary | Creatinine Clearance at Month 6 After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 6 |
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| Primary | Creatinine Clearance at Month 12 After Transplantation | Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 12 |
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| Primary | Glomerular Filtration Rate (GFR) at Month 1 After Transplantation | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure. | ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 1 |
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| Primary | GFR at Month 6 After Transplantation | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure. | ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 6 |
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| Primary | GFR at Month 12 After Transplantation | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure. | ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point. | Posted | Mean | Standard Deviation | mL/min | Month 12 |
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| Secondary | Mean Dose of Mycophenolate Mofetil | ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points. | Posted | Mean | Standard Deviation | milligrams (mg) | Baseline, Months 1, 6, and 12 |
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| Secondary | Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil | Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported. | ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points. | Posted | Number | percentage of participants | Baseline, Months 1, 6, and 12 |
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| Secondary | Percentage of Participants With Acute Rejection | Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported. | Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points. | Posted | Number | percentage of participants | Baseline to Month 1, Months 2 to 6, Months 7 to 12 |
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| Secondary | Percentage of Participants With Graft Survival | Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation. | Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points. | Posted | Number | percentage of participants | Months 1, 6, and 12 |
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From Baseline up to Month 12
Safety 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 | Renal Transplant Participants | Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen. | 33 | 128 | 51 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Sudden death | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Kidney transplant rejection | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Postoperative abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
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| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
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| Ureteric anastomosis complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Pyelocaliectasis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Ureteral disorder | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Varicocele | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Hyperuricaemia | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D007165 | Immunosuppression Therapy |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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