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

NCT ID: NCT01496703

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

749 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-01-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Acute Rejection of Renal Transplant Renal Graft Loss

Keywords

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reasons for MMF dose reduction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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renal transplantation with MMF from day 1

no intervention, this is an observational retrospective trial

Intervention Type OTHER

no intervention, this is an observational retrospective trial

Interventions

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no intervention, this is an observational retrospective trial

no intervention, this is an observational retrospective trial

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Bert Bammens

Clinical Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bert Bammens, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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MMFreductionLeuven

Identifier Type: -

Identifier Source: org_study_id