Status:
TERMINATED
A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Kidney Transplant Failure and Rejection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab ...
Eligibility Criteria
Inclusion
- Patients who are male or female age 18-65 years
- Donor age 18-65 years
- Patients who are single-organ recipients (kidney only)
- Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
- Subject (recipient) is able to understand the consent form and give written informed consent
Exclusion
- Known sensitivity or contraindication to sirolimus, tacrolimus or MMF
- Patient with significant or active infection
- Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- Patients with PRA \> 20%
- Patients who are pregnant or nursing mothers
- Patients whose life expectancy is severely limited by diseases other than renal disease
- Ongoing active substance abuse, drug or alcohol
- Major ongoing psychiatric illness or recent history of noncompliance
- Significant cardiovascular disease (e.g.):
- Significant non-correctable coronary artery disease
- Ejection fraction below 30%
- History of recent myocardial infarction
- Malignancy within 3 years, excluding non-melanoma skin cancers
- Serologic evidence of infection with HIV or HBVsAg positive
- Patients with a screening/baseline total white blood cell count \< 4,000/mm3; platelet count \< 100,000/mm3; triglycerides \> 400 mg/dl; total cholesterol \> 300 mg/dl
- Investigational drug within 30 days prior to transplant surgery
- Anti-T cell therapy within 30 days prior to transplant surgery
- Patients using Prednisone
- Patients who are ABO incompatible
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00166712
Start Date
April 1 2005
End Date
April 1 2010
Last Update
October 26 2015
Active Locations (1)
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1
Northwestern University/Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611