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

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Organ Transplantation; Transplantation Immunology

Intervention: anti-thymocyte globulin (rabbit) (Drug); anti-thymocyte globulin (rabbit) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
E. Steve Woodle, MD, Principal Investigator, Affiliation: University of Cincinnati
Adele Rike, PharmD, Principal Investigator, Affiliation: The Christ Hospital

Summary

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

Clinical Details

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 Maintenance Immunosuppression

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

Primary outcome: Composite end point of acute rejection, graft survival or patient survival

Secondary outcome:

Incidence of treatment failures: defined as the percentage of patients that do not remain on initial therapy.

Incidence of infections

Need for antilymphocyte antibody therapy to treat acute rejection

Severity of biopsy-proven rejection using Banff 97 Criteria

Delayed Graft Function

Serum creatinine

Malignancy

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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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Locations and Contacts

The Christ Hospital, Cincinnati, Ohio 45219, United States
Additional Information

Starting date: September 2008
Last updated: July 9, 2012

Page last updated: August 23, 2015

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