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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

December 17, 2011
December 20, 2011
January 1996
December 2008   (final data collection date for primary outcome measure)
reasons for dose reduction of MMF [ Time Frame: 400 days post-transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01496703 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Reasons for Mycophenolate Mofetil Dose Reduction and Impact on Graft Outcome in Renal Transplant Recipients
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

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Acute Rejection of Renal Transplant
  • Renal Graft Loss
Other: no intervention, this is an observational retrospective trial
no intervention, this is an observational retrospective trial
renal transplantation with MMF from day 1
Intervention: Other: no intervention, this is an observational retrospective trial
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
749
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01496703
MMFreductionLeuven
No
Bert Bammens, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Bert Bammens, MD,PhD Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
December 2011

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