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Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease

Intervention: Rabbit Antithymocyte globulin (Drug); Daclizumab (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Medical University of South Carolina

Official(s) and/or principal investigator(s):
Kenneth D Chavin, MD,PhD, Study Chair, Affiliation: Medical University of South Carolina
Nicole Pilch, PharmD, Study Chair, Affiliation: Medical University of South Carolina
David Taber, PharmD, Study Chair, Affiliation: Medical University of South Carolina
Prabhakar Baliga, MD, Principal Investigator, Affiliation: Medical University of South Carolina

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).

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: 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.

Secondary outcome:

Evaluate the safety and tolerability of rabbit anti-thymocyte globulin or daclizumab or basiliximab in combination with tacrolimus, corticosteroids and mycophenolate mofetil.

Proportion of patients requiring antilymphocyte therapy for acute rejection.

Patient and graft survival at one year post-transplant

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

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

Patient weight change

Incidence and severity of hypercholesterolemia (total cholesterol, HDL cholesterol, LDL cholesterol) and hypertriglyceridemia and treatment of hyperlipidemia, as defined in NCEP III guidelines

Incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers.

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

Incidence of thrombocytopenia, defined as a platelet count of less than 100,000 cells/mm3

Incidence of anemia, defined as a hemoglobin of less than 10 g/dL and need for erythropoietin or similar agents

Determine the impact of genotyping using microarray analysis on clinical outcomes and histologic findings

Utilizing the EuroQoL survey, determine if there is a correlation between graft function and quality of life

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information

Starting date: March 2009
Last updated: February 28, 2014

Page last updated: August 23, 2015

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