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CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients

NCT00737659 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2010-03-26

No results posted yet for this study

Summary

In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal transplant rejection. Still, they can cause side effect.

Research in renal transplant tries to find the best treatment in order to avoid renal rejection on one hand and to reduce as much as possible the undesired adverse and toxicity effects on the other hand.

Therapeutic efficacy and the onset of adverse effects are influenced by levels of mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).

The primary objective of this study is to assess the treatment superiority of CellCept® Dose Adjustment treatment, based on individual MPA concentration value monitored periodically, against treatment with CellCept® Fixed Dose (standard care).

Conditions

  • Renal Transplant

Interventions

DRUG

Mycophenolate mofetil (CellCept® )

Concentration Control group: MMF dosage will be adjusted (by addition or subtraction of least 250 mg of MMF twice a day) based on MPA levels (MPA AUC target of 40 mg\*h\\L) measured on Days 7,14,Months 1,3,6 and 12.

DRUG

Mycophenolate mofetil (CellCept® )

Fixed Dose group, MMF dosage will be adjusted based on standard care

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Eytan Mor, Prof. · Rabin Medical Center

  • Richard Nakache, Prof. · Sorasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-08-31
Completion
2013-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737659 on ClinicalTrials.gov