A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

Kidney Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407160
• Other study ID #: 04-245
• Status: Completed
• Start date: August 2004
• Est. completion date: January 2011

Study information

• Verified date: December 2012
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival	Cumulative graft survival at 1 year	1 year
Secondary	rejection episodes	1 year cumulative freedom from rejection	1 year