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

NCT ID: NCT00771745

Last Updated: 2016-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-07-31

Brief Summary

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

Detailed Description

We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.

Conditions

Renal Transplant Rejection; Transplants and Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

rATG 4 doses

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

Group Type: ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type: 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

rATG 3 doses

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

Group Type: ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type: DRUG

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

Interventions

Thymoglobulin

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

Intervention Type: DRUG

Thymoglobulin

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

Intervention Type: DRUG

Other Intervention Names

Anti-thymocyte globulin (rabbit), thymoglobulin; rATG; anti-thymocyte globulin (rabbit), thymoglobulin; rATG

Eligibility Criteria

Inclusion Criteria

1. Adult living donor renal transplant recipient.

2. Patient is at least 18 years of age

3. 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.

4. Signed informed consent.

Exclusion Criteria

1. Human Leukocyte Antibody (HLA) identical living donor transplant recipient.

2. History of a positive cross-match with the donor.

3. Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.

4. Patients who have previously received a kidney transplant.

5. Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).

6. History of noncompliance.

7. History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .

8. Multiple organ transplant recipient.

9. Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.

10. Patient who does not agree to use effective birth control during the 6-month efficacy analysis.

11. Known contraindication to administration of rabbit antithymocyte globulin.

12. Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3

13. Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.

14. 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.

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

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

E. Steve Woodle

MD, FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

E. Steve Woodle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Adele Rike, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital

Locations

The Christ Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

Pre-Tx Thymo

Identifier Type: -

Identifier Source: org_study_id