Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

NCT ID: NCT00859131

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-07-31

Brief 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).

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Thymoglobulin

Subjects receiving Thymoglobulin as induction agent in renal transplantation

Group Type: ACTIVE_COMPARATOR

Rabbit Antithymocyte globulin

Intervention Type: DRUG

1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4

Zenapax

subject who will receive daclizumab or basiliximab as induction agent in renal transplantation

Group Type: ACTIVE_COMPARATOR

Daclizumab

Intervention Type: DRUG

1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Interventions

Rabbit Antithymocyte globulin

1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4

Intervention Type: DRUG

Daclizumab

1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Intervention Type: DRUG

Other Intervention Names

Thymoglobulin; daclizumab, zenapax

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth D Chavin, MD,PhD

Role: STUDY_CHAIR

Medical University of South Carolina

Nicole Pilch, PharmD

Role: STUDY_CHAIR

Medical University of South Carolina

David Taber, PharmD

Role: STUDY_CHAIR

Medical University of South Carolina

Prabhakar Baliga, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Palanisamy AP, Al Manasra AR, Pilch NA, Dowden JE, Nadig SN, McGillicuddy JW, Baliga PK, Chavin KD, Taber DJ. Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients. Clin Transplant. 2015 Mar;29(3):222-6. doi: 10.1111/ctr.12507. Epub 2015 Jan 27.

Reference Type: DERIVED

PMID: 25557762 (View on PubMed)

Pilch NA, Taber DJ, Moussa O, Thomas B, Denmark S, Meadows HB, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD. Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation. Ann Surg. 2014 May;259(5):888-93. doi: 10.1097/SLA.0000000000000496.

Reference Type: DERIVED

PMID: 24513787 (View on PubMed)

Other Identifiers

thymo vs IL2

Identifier Type: -

Identifier Source: org_study_id