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Completed

NCT Number: NCT01496703

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

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).

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Key information

Conditions

Acute Rejection of Renal Transplant Renal Graft Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no intervention, this is an observational retrospective trial

Other

no intervention, this is an observational retrospective trial

Primary outcomes

  1. reasons for dose reduction of MMF

    Time frame: 400 days post-transplantation

Secondary outcomes

  1. occurence of acute rejection

    Time frame: 400 days post-transplantation

  2. graft survival

    Time frame: 400 days post-transplantation

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Important dates

Study start
1996
Primary completion
2008
Study completion
2008
First posted
Dec 21, 2011
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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