A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2011-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 Standard Immunosuppression

Anti-thymocyte Globulin (Rabbit)\] ,tacrolimus, mycophenolate mofetil and prednisone

Patients with End Stage Renal Disease (ESRD) and high Panel Reactive Antibody (PRA) who randomize 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.

No interventions assigned to this group

Group 2 Campath Immunosuppression

Alemtuzumab,tacrolimus

Patients with ESRD and high PRA who randomize 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).

No interventions assigned to this group

Eligibility Criteria

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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 human chorionic gonadotropin(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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No