Status:
UNKNOWN
CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients
Lead Sponsor:
Rabin Medical Center
Conditions:
Renal Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 immunosuppres...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00737659
Start Date
August 1 2008
End Date
August 1 2013
Last Update
March 26 2010
Active Locations (2)
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1
Rabin Medical Center
Petach Tikvah, Israel
2
Tel Aviv sourasky Medical Center
Tel Aviv, Israel