Pilot Study for HLA Identical Living Donor Renal Transplant Recipients

Completed · Phase 4

Conditions studied: Renal Transplant

In brief

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).

Key facts

Study ID

NCT00352092

Run by

University of Cincinnati

People needed

20

Starts

2002-06-01

Expected to finish

2007-12-01

Last updated by the study team

2014-11-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 70 years
• Male/female recipients
• All ethnic groups
• Negative pregnancy test
• Practicing an acceptable form of birth control
• Signing informed consent

You may not qualify if…

• 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

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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