Trials / Completed
CompletedNCT00407160
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- The University of Texas Medical Branch, Galveston · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2006-12-04
- Last updated
- 2019-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00407160. Inclusion in this directory is not an endorsement.