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A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00407160
First received: November 21, 2006
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition
Kidney Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Estimated Enrollment: 60
Study Start Date: August 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

Patients with ESRD and high PRA who randomise to the control group. These patients will get induction therapy prior to transplant with Thymoglobulin 1.5 mg/kg/day for 4 days to a total dose of 6mg/kg.

They will receive maintenance immunosuppression with three drugs : tacrolimus, cellcept and prednisone.
2
Patients with ESRD and high PRA who randomise to the study group. These patients will get induction therapy prior to reperfusion of the kidney, during the transplant operation, with Campath (Alemtuzumab) 30mg, one dose. They will receive maintenance immunosuppression with tacrolimus alone (monotherapy).

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with end stage renal disease , on dialysis, who are regarded as "high immunological risk" becuase they have lost previous transplants to rejection, or have a high panel reactive antibody (PRA).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407160

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0533
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Philip G Thomas, MD UTMB Department of Surgery
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00407160     History of Changes
Other Study ID Numbers: 04-245
Study First Received: November 21, 2006
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Kidney transplant
Tolerance induction
High PRA kidney recipients

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013