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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00407160

Enrollment

Registered

2006-12-04

Start date

2004-08-31

Completion date

2011-01-31

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Keywords

Kidney transplant, Tolerance induction, High Panel Reactive Antibody (PRA) kidney recipients

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
graft survival	1 year	Cumulative graft survival at 1 year

Secondary

Measure	Time frame	Description
rejection episodes	1 year	1 year cumulative freedom from rejection

Countries

United States

Outcome results