Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

NCT00859131 | Completed Results

• 1 other identifier: thymo vs IL2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.

  One year

Secondary Outcomes (6)

• Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.

  One year

• Graft Survival at One Year Post-transplant

  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

  one year

• Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.

  One year

• Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3

  One year

Study Arms (2)

Thymoglobulin

ACTIVE COMPARATOR

Subjects receiving Thymoglobulin as induction agent in renal transplantation

Drug: Rabbit Antithymocyte globulin

Zenapax

ACTIVE COMPARATOR

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

Drug: Daclizumab

Interventions

Rabbit Antithymocyte globulin DRUG

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

Also known as: Thymoglobulin

Thymoglobulin

Daclizumab DRUG

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

Also known as: daclizumab, zenapax

Zenapax

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The patient has given written informed consent to participate in the study

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 25557762 DERIVED

• 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.

  PMID: 24513787 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

thymoglobulin; Daclizumab

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Kenneth Chavin, MD, PhD
• Organization: Medical University of South Carolina

chavinkd@musc.edu

843-792-3368

Study Officials

• Kenneth D Chavin, MD,PhD

  Medical University of South Carolina

  STUDY CHAIR

• Nicole Pilch, PharmD

  Medical University of South Carolina

  STUDY CHAIR

• David Taber, PharmD

  Medical University of South Carolina

  STUDY CHAIR

• Prabhakar Baliga, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2014
• Last Updated: April 26, 2016
• Results First Posted: April 26, 2016

Record last verified: 2014-02

Locations

US (1)