Status:
COMPLETED
Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Kidney Failure, Chronic
Diabetic Nephropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 (PR...
Detailed Description
HYPOTHESIS: mycophenolate mofetil given over 8 months to highly sensitized subjects awaiting kidney transplant, will result in a decrement in the PRA by 10% or more in approximately 40% of patients. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00446459
Start Date
April 1 2006
End Date
December 1 2008
Last Update
April 15 2010
Active Locations (1)
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1
Universtiy of Washington Medical Center
Seattle, Washington, United States, 98195