Health Condition 1: null- Induction therapy(Thymoglobuline®) on patients undergoing live donor renal transplantation
Conditions
Interventions
Intervention1: Thymoglbuline: Thymoglobuline will be adminsitered at 3mg/kg on day of transplant beginning at least 1hr prior to reperfusion of the graft and 3mg/kg on day 1 post transplant
Sponsors
Dr Vijay Kher
Eligibility
Inclusion criteria
Inclusion criteria: Recipients of first living related donor kidney transplant Aged more or equal to 18 years Male and Female If female of child bearing potential: Must not be lactating; Must have a negative serum B-HCG within 24 hrs prior to Day-0 Must agree to practice an acceptable and reliable form of contraception during the study Signed Informed Consent
Exclusion criteria
Exclusion criteria: 1. Recipients taking prednisone at the time of their transplant 2. Recipients requiring prednisone for an underlying disease 3. Recipients who are undergoing second or more transplants 4. Recipients with Hepatitis B or C infection 5. CMV sero-negative recipients receiving an organ from a CMV sero-positive donor (CMV D+/R-) 6. Pregnancy 7. Patients with Known contraindication to administration of rabbit antithymocyte globulin 8. Patients with known allergy to rabbit derived products 9. Participation in another clinical study using another non-licensed pharmaceutical 10. Inability or missing willingness to participate in the study 11. Any other significant disease or medical conditions that, in the opinion of the Investigator, may preclude participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To observe at 6 months the efficacy of two infusions of Thymoglobuline induction (3mg/kg over at least 6 hours on Day 0 and 3mg/kg over at least 6 hours on Day 1) to prevent acute rejections in a steroid free maintenance protocol in patients undergoing living donor first renal transplantationTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe at 6 months from the date of transplant, the incidence of asymptomatic CMV infections, symptomatic CMV infection/disease and treated CMV episodes in patients with steroid free immunosuppression undergoing living donor first renal transplantation with induction of ThymoglobulineTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Vijay Kher
Medanta - The Medicity
Outcome results
None listed