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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
  Purpose

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).


Condition Intervention
Acute Rejection of Renal Transplant
Renal Graft Loss
Other: no intervention, this is an observational retrospective trial

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 749
Study Start Date: January 1996
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
renal transplantation with MMF from day 1 Other: no intervention, this is an observational retrospective trial
no intervention, this is an observational retrospective trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01496703

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Bert Bammens, MD,PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Bert Bammens, Clinical Professor, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01496703     History of Changes
Other Study ID Numbers: MMFreductionLeuven
Study First Received: December 17, 2011
Last Updated: December 20, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
reasons for MMF dose reduction

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014