Status:
COMPLETED
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Kidney Transplantation
Kidney Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is ...
Detailed Description
Drugs that suppress the immune system, such as sirolimus and tacrolimus, have contributed to increased success of transplantation. However, to prevent organ rejection, transplant recipients need to ta...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)
- Receiving only a kidney and no other organs
- Able to take medications by mouth
- Willing to use acceptable methods of contraception
- Exclusion Criteria
- Received HLA-identical living-donor kidney transplant
- HLA-antigen mismatch greater than 3
- Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment
- Received a non-heart-beating donor allograft
- Received a kidney from a donor who is greater than 60 years of age
- End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)
- Previous kidney transplant
- Received multiorgan transplant
- Concomitant systemic corticosteroid therapy for other medical diseases
- Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus
- Human Immunodeficiency Virus (HIV) infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen
- Received dual or en-bloc pediatric kidneys
- Anti-human Globulin (AHG) or T cell crossmatch positive
- Investigational drug within 6 weeks of study entry
- Known clinically significant cardiovascular or cerebrovascular disease
- Previous or current history of cancer or lymphoma. Patients with adequately treated basal or squamous cell skin carcinoma are not excluded.
- Clinically significant coagulopathy or a requirement for chronic anti-coagulation therapy precluding biopsy
- Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive donor
- History of a psychological illness or condition that, in the opinion of the investigator, may interfere with the study
- Graves disease. Patients who have been previously adequately treated with radioiodine ablative therapy are not excluded.
- Active systemic infections
- Platelets less than 100,000 cells/mm\^3 at study entry
- Pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00078559
Start Date
November 1 2003
End Date
February 1 2010
Last Update
June 29 2018
Active Locations (1)
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1
University of Wisconsin - Department of Medicine
Madison, Wisconsin, United States, 53792-1735