Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.

Completed · Phase 2

Conditions studied: Kidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal

In brief

This is a 12-month, phase II, prospective, open label study, to evaluate the effect of mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of Reactive Antibody (PRA) levels. On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement Organization (OPO) increases the waiting time from 3 to 6 years. Spontaneous decreases in the PRA rarely occur and is associated with a decreased chance for transplantation and a decreased rate of survival.

Key facts

Study ID

NCT00446459

Run by

University of Washington

People needed

45

Starts

2006-04-01

Expected to finish

2008-12-01

Last updated by the study team

2010-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persons on the kidney transplant waiting list who are currently receiving hemodialysis
• Age range 18 - 75
• Outpatient status
• Patients with a PRA over 50% for over 6 months
• Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
• Patients with a PPD (purified protein derivative) test within the last 6 months. If subject has a prior history of TB (tuberculosis) or positive PPD, documentation of adequate treatment is required.
• Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use a medically acceptable method of contraception throughout the study.

You may not qualify if…

• Active infection
• History of multiple recurrent infections defined as more than 3 urinary tract infections, 2 episodes of pneumonia or 3 episodes of otitis/sinusitis in one year, or more than two dialysis line or peritoneal infections within one year. Infection with HCV (hepatitis C virus) or HBV (hepatitis B virus) or HIV (human immunodeficiency virus).
• Lack of documentation of PPD testing
• Lack of documentation of treatment of a positive PPD
• Pregnant or breast-feeding
• Baseline leukopenia, WBC < 4.0
• Thrombocytopenia (platelet count < 130) or difficult to treat anemia, HCT chronically < 32 on intravenous iron and EPO (erythropoietin) therapy
• Transfusion within 6 months

Where it is running

• Universtiy of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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