N/A
N=128
An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01672957 ↗Enrolled (actual)
128
Serious AEs
25.8%
Results posted
Oct 2016
Primary outcome: Primary: Creatinine Clearance at 1 Month After Transplantation — 65.82 mL/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Mycophenolate Mofetil (Drug); Immunosuppressive Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Creatinine Clearance at 1 Month After Transplantation |
65.82 | — |
| PRIMARY Creatinine Clearance at Month 6 After Transplantation |
73.38 | — |
| PRIMARY Creatinine Clearance at Month 12 After Transplantation |
69.69 | — |
| PRIMARY Glomerular Filtration Rate (GFR) at Month 1 After Transplantation |
53.54 | — |
| PRIMARY GFR at Month 6 After Transplantation |
56.78 | — |
| PRIMARY GFR at Month 12 After Transplantation |
58.03 | — |
| SECONDARY Mean Dose of Mycophenolate Mofetil |
2033.06; 1718.49; 1457.39; 1539.86 | — |
| SECONDARY Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil |
0.8; 0.8; 2.3; 7.2; 90.9; 99.2 | — |
| SECONDARY Percentage of Participants With Acute Rejection |
16.5; 0.8; 0.9 | — |
| SECONDARY Percentage of Participants With Graft Survival |
100; 99.2; 98.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01672957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.