Health Condition 1: null- post renal transplantation immunosuppression in the management of end stage renal disease
Conditions
Interventions
Intervention1: sirolimus: 2-6mg/day, orally for 6 months
Control Intervention1: tacrolimus or cyclosporine: tacrolimus 0.1mg/kg/day, orally, 6 months
cyclosporine 8-10mg/kg/day, orally, 6 months
Sponsors
Biocon Limited
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function assessed by serum creatinine, blood urea nitrogen and GFR estimation by MDRD methodTimepoint: 6months after enrollment in to the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute rejection  Patient and graft survival at 6 months,  Incidences of hyperlipidemia, NODM, hypertension and infectious complicationsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr. Ashok Krishna V S
Biocon Limited
Outcome results
None listed