CompletedNot Applicable

A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

United States21 participantsStarted 2004-08

Plain-language summary

Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

graft survival

Timeframe: 1 year

Trial details

NCT IDNCT00407160

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-01

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