To evaluate the effect & safety of two immunosuppresant drugs (Tacrolimus with Enteric coated Mycophenolate Sodium or Mycophenolate Mofetil) in new renal transplant recipients.
- Conditions
- Health Condition 1: null- De Novo Renal Transplant patients. End Stage kidney disease patients
- Registration Number
- CTRI/2012/02/002441
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 200
1. Male or female de novo renal transplant recipients between 18 and 70 years of age.
2. Patients who are receiving a primary cadaveric donor or non-HLA identical living donor kidney transplant (liver related haplograft).
3. Patients who have given written informed consent to participate in the study.
4. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and willing to use an effective means of contraception for the total study duration.
1. Patients who are recipients of multiple solid organ or tissue transplants (dual kidney is allowed), or have previously received an organ or tissue transplant.
2. Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant.
3. Patients with platelet count 100,000/mm at the evaluation before randomization.
4. Patients with an absolute neutrophil count of 1,500/mm³ at baseline before surgery or white blood cell count of 4,500/mm³, or leukocytopenia ( 2,500/mm3), or hemoglobin 6g/dL prior to randomization.
5. Renal cold ischemic time (CIT) 30 hours.
6. Patients with a known hypersensitivity to either study drugs or their class, or to any of excipients
7. Patients with clinically significant systemic infection at time of transplant or within two weeks of transplant.
8. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter absorption, distribution, metabolism and excretion of study medication.
9. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (-HCG) at Screen.
10. Patient is of childbearing potential (men and women) and unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of equimolar Enteric coated Mycophenolate Sodium (EC-MPS) versus Mycophenolate Mofetil (MMF) with reduced levels of tacrolimus, in de novo renal transplant recipients in terms of : <br/ ><br># Calculated Glomerular Filtration rate <br/ ><br># Serum creatinine change (%) <br/ ><br># Composite efficacy failure rate (BPAR, graft loss, death)Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method