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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

November 21, 2006
September 6, 2011
August 2004
January 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00407160 on ClinicalTrials.gov Archive Site
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A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients: Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol.

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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).

Kidney Diseases
Not Provided
  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407160
04-245
Yes
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: Philip G Thomas, MD UTMB Department of Surgery
The University of Texas, Galveston
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP