Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)
|End-Stage Renal Disease Kidney Failure||Biological: Single-dose rabbit Anti-thymocyte Globulin induction Biological: Divided-dose rabbit Anti-thymocyte Globulin induction||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Trial to Assess Safety of Single Dose vs. Traditional Administration of Thymoglobulin Induction for Renal Transplantation|
- Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function [ Time Frame: During first 7 days after kidney transplantation ]
The composite endpoint components and definitions are:
- Fever: Body temperature ≥ 38.5˚C.
- Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.
- Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.
- Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)
- Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation
- Patient Survival [ Time Frame: 12 months post-transplantation ]Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.
- Graft Survival [ Time Frame: 12 months post-transplantation ]Kaplan-Meier estimates of graft survival probability for 12 months after transplantation
- Acute Kidney Rejection [ Time Frame: 12 months post-transplantation ]Kaplan-Meier probability estimates of rejection rates
- Incomplete Thymoglobulin Infusion [ Time Frame: First 7 days post-transplantation ]
- Kidney Function [ Time Frame: 12 months post-transplantation ]Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)
|Study Start Date:||March 2010|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Single-dose Thymoglobulin
Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion
Biological: Single-dose rabbit Anti-thymocyte Globulin induction
6 mg of rATG administered in a single dose on the day of kidney transplantation
Active Comparator: Divided-dose Thymoglobulin
Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4
Biological: Divided-dose rabbit Anti-thymocyte Globulin induction
6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.
This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte globulin induction at kidney transplantation, compared to the conventional administration of the same overall dose divided into four smaller doses across four days. Two randomized groups of kidney transplant recipients will be each administered the drug Thymoglobulin according to a different dosing regimen. The control group will receive the usual and traditional regimen of a total of 6 mg/Kg divided into 4 doses, 1 on the day of transplantation and 1 each day on the next 3 days. The experimental group will receive the same total Thymoglobulin dose, 6 mg/Kg, but entirely on the day of transplantation.
The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects needed to complete the study for adequate evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906204
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Principal Investigator:||R.Brian Stevens, MD, PhD||Wright State University, Dayton, Ohio|