Overview

This trial is active, not recruiting.

Condition end stage renal disease
Treatments rabbit antithymocyte globulin, daclizumab
Sponsor Medical University of South Carolina
Collaborator Genzyme, a Sanofi Company
Start date March 2009
End date July 2012
Trial size 200 participants
Trial identifier NCT00859131, thymo vs IL2

Summary

The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Subjects receiving Thymoglobulin as induction agent in renal transplantation
rabbit antithymocyte globulin Thymoglobulin
1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
(Active Comparator)
subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
daclizumab daclizumab, zenapax
1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Primary Outcomes

Measure
Treatment efficacy will be defined as the incidence of all biopsy proven acute rejection and calculated creatinine clearance using the abbreviated MDRD equation at one year post-transplant.
time frame: One year

Secondary Outcomes

Measure
Evaluate the safety and tolerability of rabbit anti-thymocyte globulin or daclizumab or basiliximab in combination with tacrolimus, corticosteroids and mycophenolate mofetil.
time frame: One year
Proportion of patients requiring antilymphocyte therapy for acute rejection.
time frame: One year
Patient and graft survival at one year post-transplant
time frame: One year
Incidence of post-transplant diabetes mellitus (PTDM), defined as post-discharge new need for insulin or oral hypoglycemic agents and meeting current ADA diagnostic criteria for diabetes mellitus
time frame: One year
Incidence of post-transplant infections, including, but not limited to, CMV infection and disease, BK infection and nephropathy, other opportunistic infections, urinary tract infections, pneumonia, and sepsis
time frame: one year
Patient weight change
time frame: one year
Incidence and severity of hypercholesterolemia (total cholesterol, HDL cholesterol, LDL cholesterol) and hypertriglyceridemia and treatment of hyperlipidemia, as defined in NCEP III guidelines
time frame: One year
Incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers.
time frame: One year
Incidence of leukopenia, defined as a total white blood cell count of less than 2,000 cells/mm3 and neutropenia, defined as an absolute neutrophil count of less than 1,000 cells/mm3 and need for colony stimulating factors
time frame: One year
Incidence of thrombocytopenia, defined as a platelet count of less than 100,000 cells/mm3
time frame: One year
Incidence of anemia, defined as a hemoglobin of less than 10 g/dL and need for erythropoietin or similar agents
time frame: One year
Determine the impact of genotyping using microarray analysis on clinical outcomes and histologic findings
time frame: One year
Utilizing the EuroQoL survey, determine if there is a correlation between graft function and quality of life
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Male and female patients between 18 and 75 years of age - Male or female patients who are primary or repeat cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients - Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion. - The patient has given written informed consent to participate in the study Exclusion Criteria: - Patient has previously received or is receiving an organ transplant other than a kidney. - Patients who are recipients of a multiple organ transplant. - Patient has received a primary or re-transplant from an HLA-identical living donor. - Any positive cross-match. - Patient is the recipient of a pediatric donor kidney from a pediatric donor aged 8 years or less. - Patient has received an ABO incompatible donor kidney. - Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive. - Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV). - Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. - Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion. - Patient is taking or has been taking an investigational drug in the 30 days prior to transplant. - Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, daclizumab or corticosteroids. - Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication. - Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin. - Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test. - Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study. - Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. - Inability to cooperate or communicate with the investigator.

Additional Information

Official title Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.
Principal investigator Prabhakar Baliga, MD
Description A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.