Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
Condition: Kidney Failure, Chronic; Diabetic Nephropathies; Glomerulonephritis, IGA; Hypertension, Renal
MeSH terms: Kidney Diseases; Renal Insufficiency; Diabetic Nephropathies; Kidney Failure, Chronic; Glomerulonephritis; Glomerulonephritis, IGA; Hypertension, Renal; Hypertension
Intervention: mycophenolate mofetil (CellCept)
Intervention description: 500mg - 1,000mg, taken PO, twice daily.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CellCept; Dialysis; Kidney; Renal; Nephropathy; Glomerulonephropathy; Immunosuppression; Allograft; Compatibility; HLA; PRA; Transplant; Sensitization; Antibodies; Diabetes; Hypertension; Transplantation, Kidney

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 (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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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