Low Dose Thymoglobin in Renal Transplant Patients
This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Dose Thymoglobulin As Induction Agent on Predbisone-Free Regimens of Renal Transplant Recipients|
- Evaluate the rates of acute cellular rejection between study groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]Data from study participants will be collected for up to 1 year post-transplant.
- Evaluate the rates of infections, leucopenia and malignacy between study groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]Data from study participants will be collected for up to 1 year post-transplant.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Thymoglobulin 1.25mg/kg dose
The safety and efficacy of low dose Thymoglobulin (1.25mg/kg) as an induction agent in renal transplant subjects.
Thymoglobulin 1.25mg/kg dose
Other Name: Thymoglobulin
Experimental: Thymoglobulin 0.75mg/kg dose
The safety and efficacy of low dose Thymoglobulin (0.75mg/kg) as an induction agent in renal transplant subjects.
Drug: Thymoglobulin 0.75mg/kg dose
Other Name: Thymoglobulin
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|Contact: Monica Grafals, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Contact: Monica Grafals, MD 781-744-2500 email@example.com|
|Sub-Investigator: James Pomposelli, MD|
|Sub-Investigator: Khalid Kwaja, MD|
|Sub-Investigator: Hannah Gilligan, MD|
|Sub-Investigator: Mohamed Akoud, MD|
|Sub-Investigator: Mary Anne Simpson|
|Sub-Investigator: Elizabeth Pomfret, MD|
|Principal Investigator:||Monica Grafals, MD||Lahey Clinic|