Reasons for Mycophenolate Mofetil Dose Reduction and Impact on Graft Outcome in Renal Transplant Recipients

Completed

• Conditions: Acute Rejection of Renal Transplant; Renal Graft Loss
• Interventions: Other: no intervention, this is an observational retrospective trial

• Registration Number: NCT01496703
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. However, MMF-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. Methods: Retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with MMF as part of their initial maintenance immunosuppressive protocol (n=749).

Detailed Description

Not available

Study Timeline

• Study Start: 1996-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2011-12
• Study First Submitted: 2011-12-17
• Study First Submitted QC: 2011-12-20
• Last Update Submitted: 2011-12-20
• Study First Posted: 2011-12-21
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 749

Inclusion Criteria

• All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis.

Exclusion Criteria

• If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
renal transplantation with MMF from day 1	no intervention, this is an observational retrospective trial	-

Primary Outcome Measures

Name	Time	Method
reasons for dose reduction of MMF	400 days post-transplantation

Secondary Outcome Measures

Name	Time	Method
occurence of acute rejection	400 days post-transplantation
graft survival	400 days post-transplantation

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium