A clinical trial to compare the safety and efficacy of CNI's and sirolimus in renal transplant recipients
- Conditions
- Health Condition 1: null- post renal transplantation immunosuppression in the management of end stage renal disease
- Registration Number
- CTRI/2011/091/000034
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Men and women renal transplant recipients >= 18yrs old
ï?· Undergone denovo live donor renal transplantation >= 3 months prior to enrollment
ï?· Receiving CNI based regimen after transplantation
ï?· Serum creatinine <= 2.5mg/dl and Proteinuria <=800mg/day
Pregnant, nursing mothers or women of childbearing potential without an effective method of birth control.
 Renal transplant recipients who had episodes of acute rejection, delayed graft failure or signs of graft failure
 Patients suffering from any malignancy requiring immediate surgery, ongoing chemotherapy or radiation
 Patients suffering from any acute systemic infections within 30 days prior to enrollment
 Use of any investigational drug upto 4 weeks prior to enrolling in the study
 Patients requiring second renal transplantation or Multiple organ transplantation
 Patients having any other systemic disease which may aggravate or prevent him to undergo immunosuppression
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method