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

Acute Rejection of Renal Transplant Clinical Trial

Official title:

Reasons for Dose Reduction of Mycophenolate Mofetil During the First Post-transplant Year in Renal Transplant Recipients and Its Impact on Graft Outcome: a Single-center Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496703
• Other study ID #: MMFreductionLeuven
• Status: Completed
• Phase: N/A
• First received: December 17, 2011
• Last updated: December 20, 2011
• Start date: January 1996
• Est. completion date: December 2008

Study information

• Verified date: December 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Rejection of Renal Transplant
• Renal Graft Loss

Intervention

Other:
• no intervention, this is an observational retrospective trial
no intervention, this is an observational retrospective trial

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reasons for dose reduction of MMF		400 days post-transplantation	Yes
Secondary	occurence of acute rejection		400 days post-transplantation	Yes
Secondary	graft survival		400 days post-transplantation	Yes