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

Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Immunosuppression

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

Study Overview

• Status: Completed
• Conditions: Renal Transplant Rejection; Transplants and Implants
• Intervention / Treatment: Drug: Thymoglobulin; Drug: Thymoglobulin

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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; Other Names: rATG; Anti-thymocyte globulin (rabbit), thymoglobulin; 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; Other Names: rATG; anti-thymocyte globulin (rabbit), thymoglobulin
Active Comparator: 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	Drug: 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; Other Names: rATG; Anti-thymocyte globulin (rabbit), thymoglobulin; 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; Other Names: rATG; anti-thymocyte globulin (rabbit), thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Malignancy	Undefined

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Genzyme, a Sanofi Company
• Investigators: Principal Investigator: Adele Rike, PharmD, The Christ Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 10, 2008
• First Submitted That Met QC Criteria: October 10, 2008
• First Posted (Estimate): October 13, 2008

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Thymoglobulin; Antilymphocyte Serum
• Other Study ID Numbers: Pre-Tx Thymo