Status:
COMPLETED
Pilot Study for HLA Identical Living Donor Renal Transplant Recipients
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Renal Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a livin...
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a livin...
Eligibility Criteria
Inclusion
- Age 18 to 70 years
- Male/female recipients
- All ethnic groups
- Negative pregnancy test
- Practicing an acceptable form of birth control
- Signing informed consent
Exclusion
- Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
- Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
- Liver, heart, pancreas or small bowel transplant recipient
- Fasting total cholesterol \>300 mg/dL and fasting triglycerides \>400 mg/dL
- Baseline WBC count \<3000/cu.mm
- Baseline platelet count \<100,000/cu.mm
- Known or suspected malignancy within previous 3 years, (Patients with squamous cell and basal skin cancer are not excluded)
- Active systemic infection
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00352092
Start Date
June 1 2002
End Date
December 1 2007
Last Update
November 13 2014
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267