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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bert Bammens, Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01496703

First received: December 17, 2011

Last updated: December 20, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 17, 2011

Last Updated Date

December 20, 2011

Start Date ^ICMJE

January 1996

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

reasons for dose reduction of MMF [ Time Frame: 400 days post-transplantation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01496703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

occurence of acute rejection [ Time Frame: 400 days post-transplantation ] [ Designated as safety issue: Yes ]
graft survival [ Time Frame: 400 days post-transplantation ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Acute Rejection of Renal Transplant
Renal Graft Loss

Intervention ^ICMJE

Other: no intervention, this is an observational retrospective trial

no intervention, this is an observational retrospective trial

Study Group/Cohort (s)

renal transplantation with MMF from day 1

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

749

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01496703

Other Study ID Numbers ^ICMJE

MMFreductionLeuven

Has Data Monitoring Committee

Responsible Party

Bert Bammens, Universitaire Ziekenhuizen Leuven

Study Sponsor ^ICMJE

Universitaire Ziekenhuizen Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bert Bammens, MD,PhD

Universitaire Ziekenhuizen Leuven

Information Provided By

Universitaire Ziekenhuizen Leuven

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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