We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00407160
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : September 7, 2011
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease
Kidney Diseases

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : August 2004
Primary Completion Date : January 2011
Study Completion Date : January 2011


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.

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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407160

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0533
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Principal Investigator: Philip G Thomas, MD UTMB Department of Surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00407160     History of Changes
Other Study ID Numbers: 04-245
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by The University of Texas Medical Branch, Galveston:
Kidney transplant
Tolerance induction
High PRA kidney recipients

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action