Pilot Study for HLA Identical Living Donor Renal Transplant Recipients

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 living donor that is HLA-identical (has a similar immune system).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Roche Pharma AG
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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