Status:
COMPLETED
A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Kidney Diseases
Eligibility:
All Genders
18-75 years
Brief Summary
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.
Detailed Description
Recent reports suggest that it might be possible to induce a state of tolerance in solid organ transplantation. So called "tolerogenic immunosuppression" involves induction with lymphocyte depleting a...
Eligibility Criteria
Inclusion
- Males and females aged 18-75 years.
- Recipients of multiple kidney transplants
- Patients with a PRA \>14% and/or a past historical PRA greater or equal to 50%.
- Females of childbearing potential must have a negative pregnancy test prior to inclusion.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Exclusion
- Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hCG) laboratory test.
- Patients who are HIV positive.
- Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00407160
Start Date
August 1 2004
End Date
January 1 2011
Last Update
March 4 2019
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0533