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

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. Identifier: NCT00737659
Recruitment Status : Unknown
Verified December 2008 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : August 19, 2008
Last Update Posted : March 26, 2010
Information provided by:
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE August 17, 2008
First Posted Date  ICMJE August 19, 2008
Last Update Posted Date March 26, 2010
Study Start Date  ICMJE August 2008
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Primary Endpoint Treatment failure defined as a biopsy proven acute rejection, graft loss, death, MMF discontinuation or lost to follow-up. [ Time Frame: During the first 12 months following randomization. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00737659 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients
Official Title  ICMJE Phase IV, Open-Label, Multicenter, Randomized Study Comparing Mycophenolate Mofetil (MMF) Dose Adjustment Based on Blood MPA Concentration to Standard Care Treatment With MMF in Renal Transplant Recipients Receiving Tacrolimus
Brief 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).

Detailed Description Patient will be randomized into two treatment groups on a 1:1 ratio. Both groups will be treated with the same drugs which is the usual treatment for avoiding renal transplant rejection. In one group the CellCept® dose will be adjusted based on MPA concentration value which will be monitored periodically; and the second group will be treated with CellCept® Fixed Dose (based on the clinical judgment of the treating physician).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Transplant
Intervention  ICMJE
  • 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.
    Other Names:
    • CellCept®
    • MMF
  • Drug: Mycophenolate mofetil (CellCept® )
    Fixed Dose group, MMF dosage will be adjusted based on standard care
Study Arms  ICMJE
  • Experimental: 1
    Concentration Controlled (CC)group will receive an individually adjusted MMF dosing regimen based on the plasma concentrations of mycophenolic acid (MPA,the active metabolite of mycophenolate mofetil).
    Intervention: Drug: Mycophenolate mofetil (CellCept® )
  • Active Comparator: 2
    Fixed dose (FD) group will receive an a priori set dose of 2mg\day MMF, the recommended dose, with a possible secondary adaptation by the clinician based on criteria of clinical efficacy, toxicity or interactions with other medications.
    Intervention: Drug: Mycophenolate mofetil (CellCept® )
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, between 18 to 70 years of age at the time of enrollment.
  • Patient who received first or second renal transplant.
  • Patients who are 0-14 days post transplant.
  • Patients capable of understanding the purposes and risks of the study who signed a written informed consent to participate and to comply with the requirements of the study.

Exclusion Criteria:

  • Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the study drug therapy.
  • Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
  • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
  • Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
  • Current or historic Panel Reactive Antibody (PRA) >50%
  • Positive crossmatch (irrespective of method).
  • Cold ischemia time of the graft of more than 30 hours.
  • Patients who had received an investigational new drug within the last three months at the time of enrollment.
  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  • Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
  • Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
  • Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
  • Previous exposure to EC-MPS.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00737659
Other Study ID Numbers  ICMJE ML21706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eytan Mor Prof., Rabin MC
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eytan Mor, Prof. Rabin Medical Center
Principal Investigator: Richard Nakache, Prof. Sorasky Medical Center
PRS Account Rabin Medical Center
Verification Date December 2008

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