Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

NCT00771745 | Completed Phase 4 Results

• 1 other identifier: Pre-Tx Thymo
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

Conditions

Renal Transplant Rejection; Transplants and Implants

Outcome Measures

Primary Outcomes (1)

• Composite End Point of Acute Rejection, Graft Loss or Patient Death

  Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death

  6 months

Secondary Outcomes (6)

• Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.

  Ongoing

• Incidence of Infections

  Not defined

• Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection

  Not defined

• Severity of Biopsy-proven Rejection Using Banff 97 Criteria

  Not defined

• Serum Creatinine

  Post-operative days 1-7, 30, 90 and 6 months

Study Arms (2)

rATG 4 doses

ACTIVE COMPARATOR

Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

Drug: Thymoglobulin

rATG 3 doses

ACTIVE COMPARATOR

Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

Drug: Thymoglobulin

Interventions

Thymoglobulin DRUG

Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF

Also known as: Anti-thymocyte globulin (rabbit), thymoglobulin, rATG

rATG 4 doses

Eligibility Criteria

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

You may qualify if:

• Adult living donor renal transplant recipient.
• Patient is at least 18 years of age
• If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
• Signed informed consent.

You may not qualify if:

• Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
• History of a positive cross-match with the donor.
• Patients with a peak CDC PRA \> 50% or a current CDC PRA \> 25%.
• Patients who have previously received a kidney transplant.
• Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• History of noncompliance.
• History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
• Multiple organ transplant recipient.
• Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
• Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
• Known contraindication to administration of rabbit antithymocyte globulin.
• Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
• Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.

Sponsors & Collaborators

• University of Cincinnati: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Interventions

thymoglobulin; Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Rita Alloway
• Organization: University of Cincinnati

Rita.Alloway@uc.edu

513-558-1568

Study Officials

• E. Steve Woodle, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Adele Rike, PharmD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 18, 2016
• Results First Posted: November 23, 2015

Record last verified: 2015-12

Locations

US (1)