Clinical trial NCT00771745: Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant Rejection
Transplants and Implants
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2008-10-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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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Primary outcomes:
measure: Composite End Point of Acute Rejection, Graft Loss or Patient Death
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.
timeFrame: Ongoing
measure: Incidence of Infections
timeFrame: Not defined
measure: Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection
timeFrame: Not defined
measure: Severity of Biopsy-proven Rejection Using Banff 97 Criteria
timeFrame: Not defined
measure: Serum Creatinine
timeFrame: Post-operative days 1-7, 30, 90 and 6 months
measure: Malignancy
timeFrame: Undefined
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: E. Steve Woodle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Christ Hospital
name: Adele Rike, PharmD
role: PRINCIPAL_INVESTIGATOR
References: