Induction therapy with Thymoglobuline in live donor renal transplant

Not Applicable

• Conditions: Health Condition 1: null- Induction therapy(Thymoglobuline®) on patients undergoing live donor renal transplantation

• Registration Number: CTRI/2011/05/001743
• Lead Sponsor: Dr Vijay Kher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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