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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 Maintenance Immunosuppression


Phase 4
18 Years
N/A
Not Enrolling
Both
Organ Transplantation, Transplantation Immunology

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Trial Information

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 Maintenance Immunosuppression


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.


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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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Composite end point of acute rejection, graft survival or patient survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

E. Steve Woodle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati

Authority:

United States: Institutional Review Board

Study ID:

Pre-Tx Thymo

NCT ID:

NCT00771745

Start Date:

September 2008

Completion Date:

July 2010

Related Keywords:

  • Organ Transplantation
  • Transplantation Immunology

Name

Location

The Christ HospitalCincinnati, Ohio  45219