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A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Diseases

Phase: N/A

Status: Completed

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
Philip G Thomas, MD, Principal Investigator, Affiliation: UTMB Department of Surgery

Summary

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

Clinical Details

Official title: Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients: Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol.

Study design: Observational Model: Cohort, Time Perspective: Prospective

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 antibodies followed by monotherapy with calcineurin inhibitors, cyclosporin or tacrolimus. The proposed study aims to evaluate a protocol of immunosuppression induction with lymphocyte depleting antibody Campath given prior to graft reperfusion, followed by tacrolimus monotherapy in highly sensitized patients (PRA >14% or past historical =/>50% and/or multiple renal transplants) undergoing renal transplantation, and compare it with the current standard protocol at UTMB which employs induction with Thymoglobulin given over 4 days followed by 3 drugs: tacrolimus, mycophenolate and steroids. In both groups of patients the target tacrolimus levels will be the same i. e, between 10 to 15ng/mL, soon after the transplant. In the Campath gro up, tacrolimus will be tapered after 3 months in patients who do not have rejection and appear to be developing donor specific tolerance.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males and females aged 18-75 years. 2. Recipients of multiple kidney transplants 3. Patients with a PRA >14% and/or a past historical PRA greater or equal to 50%. 4. Females of childbearing potential must have a negative pregnancy test prior to inclusion. 5. 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: 1. Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin. 2. 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 hCG laboratory test. 3. Patients who are HIV positive. 4. Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.

Locations and Contacts

University of Texas Medical Branch, Galveston, Texas 77555-0533, United States
Additional Information

Related publications:

Calne RY. Prope tolerance: a step in the search for tolerance in the clinic. World J Surg. 2000 Jul;24(7):793-6. Review.

Magliocca JF, Knechtle SJ. The evolving role of alemtuzumab (Campath-1H) for immunosuppressive therapy in organ transplantation. Transpl Int. 2006 Sep;19(9):705-14. Review.

Starting date: August 2004
Last updated: September 6, 2011

Page last updated: August 23, 2015

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