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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00446459
• Date of registration: 09/03/2007
• Primary sponsor: University of Washington
• Public title: Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
• Scientific title: The Highly Sensitized Patients: Effects of Mycophenolate Mofetil (MMF) On Anti-Human Leukocyte Antigen (HLA) Antibody Levels In Patients Awaiting Cadaveric Renal Transplant
• Date of first enrolment: April 2006
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00446459
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Connie L Davis, MD
• Affiliation: University of Washington

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Nephropathies

Glomerulonephritis, IGA

Hypertension, Renal

Kidney Failure, Chronic

Intervention(s)

Drug: mycophenolate mofetil (CellCept)

Primary Outcome(s)

The Number of Subjects With a 10% Decrease in PRA Level at Month 8. [Time Frame: Enrollment to month 8]

Secondary Outcome(s)

The Number of Kidney Transplant up to 12 Months. [Time Frame: Enrollment to month 8 or month 12 post enrollment.]

The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL). [Time Frame: Enrollment to month 12.]

The Number of Subjects With Significant Infections up to Month 12. [Time Frame: From enrollment to month 12.]

The Number of Transplants With a Negative Crossmatch at Transplant. [Time Frame: Number of Transplants with a Negative Crossmatch.]

Secondary ID(s)

03-7915-A

24223-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche