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

Renal Transplant Clinical Trial

— MMF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00737659
• Other study ID #: ML21706
• Status: Recruiting
• Phase: Phase 4
• First received: August 17, 2008
• Last updated: March 25, 2010
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2008
• Source: Rabin Medical Center
• Contact: Eytan Mor, Prof.
• Phone: +972-39376452
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: August 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant

Intervention

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.
• Mycophenolate mofetil (CellCept® )
Fixed Dose group, MMF dosage will be adjusted based on standard care

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikvah
Israel	Tel Aviv sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint Treatment failure defined as a biopsy proven acute rejection, graft loss, death, MMF discontinuation or lost to follow-up.		During the first 12 months following randomization.	Yes