An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
- Conditions
- Kidney Transplantation
- Interventions
- Drug: Immunosuppressive Therapy
- Registration Number
- NCT01672957
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- Participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil in accordance with the indication provided by the SmPC of mycophenolate mofetil
- Date of study enrollment is the date of kidney transplantation
- Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like: Hypersensitivity to active ingredient or any of the excipients of the product; Pregnancy and lactation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Renal Transplant Participants Immunosuppressive Therapy 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). Renal Transplant Participants Mycophenolate Mofetil 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).
- Primary Outcome Measures
Name Time Method GFR at Month 12 After Transplantation Month 12 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.
Creatinine Clearance at 1 Month After Transplantation Month 1 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.
Creatinine Clearance at Month 6 After Transplantation Month 6 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.
Creatinine Clearance at Month 12 After Transplantation Month 12 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.
Glomerular Filtration Rate (GFR) at Month 1 After Transplantation Month 1 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.
GFR at Month 6 After Transplantation Month 6 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil Baseline, Months 1, 6, and 12 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.
Percentage of Participants With Acute Rejection Baseline to Month 1, Months 2 to 6, Months 7 to 12 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.
Percentage of Participants With Graft Survival Months 1, 6, and 12 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.
Mean Dose of Mycophenolate Mofetil Baseline, Months 1, 6, and 12