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

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Renal Transplant Rejection; Transplants and Implants

Treatments: Drug: Thymoglobulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00771745

Pre-Tx Thymo

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

rATG 4 doses

Active Comparator group

Description:

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

Treatment:

Drug: Thymoglobulin

Drug: Thymoglobulin

rATG 3 doses

Active Comparator group

Description:

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

Treatment:

Drug: Thymoglobulin

Drug: Thymoglobulin