An Observation study of Thymoglobuline as Induction therapy in a steriod free maintenance immuno-supressive protocol for INDIAN patients undergoing live donor renal transplantation - OTIS-INDIA

Dr Vijay Kher0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

Dr Vijay Kher