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

NCT01496703 | Completed

• 1 other identifier: MMFreductionLeuven
• Study Type: observational
• Target: 749
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Rejection of Renal Transplant; Renal Graft Loss

Keywords

reasons for MMF dose reduction

Outcome Measures

Primary Outcomes (1)

• reasons for dose reduction of MMF

  400 days post-transplantation

Secondary Outcomes (2)

• occurence of acute rejection

  400 days post-transplantation

• graft survival

  400 days post-transplantation

Study Arms (1)

renal transplantation with MMF from day 1

Other: no intervention, this is an observational retrospective trial

Interventions

no intervention, this is an observational retrospective trial OTHER

no intervention, this is an observational retrospective trial

renal transplantation with MMF from day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered. No other exclusion criteria were applied.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Bert Bammens, MD,PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: December 17, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 1996
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

BE (1)