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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:
ClinicalTrials.gov Identifier:
NCT01496703
First Posted: December 21, 2011
Last Update Posted: December 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bert Bammens, Universitaire Ziekenhuizen Leuven
  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 Bert Bammens, Universitaire Ziekenhuizen Leuven:

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

Secondary Outcome Measures:
  • occurence of acute rejection [ Time Frame: 400 days post-transplantation ]
  • graft survival [ Time Frame: 400 days post-transplantation ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bert Bammens, Clinical Professor, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01496703     History of Changes
Other Study ID Numbers: MMFreductionLeuven
First Submitted: December 17, 2011
First Posted: December 21, 2011
Last Update Posted: December 21, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action