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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00446459
First received: March 9, 2007
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
Diabetic Nephropathies
Glomerulonephritis, IGA
Hypertension, Renal
Drug: mycophenolate mofetil (CellCept)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Highly Sensitized Patients: Effects of Mycophenolate Mofetil (MMF) On Anti-Human Leukocyte Antigen (HLA) Antibody Levels In Patients Awaiting Cadaveric Renal Transplant

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • The Number of Subjects With a 10% Decrease in PRA Level at Month 8. [ Time Frame: Enrollment to month 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Subjects With Significant Infections up to Month 12. [ Time Frame: From enrollment to month 12. ] [ Designated as safety issue: Yes ]
    The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.

  • The Number of Kidney Transplant up to 12 Months. [ Time Frame: Enrollment to month 8 or month 12 post enrollment. ] [ Designated as safety issue: No ]
    The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.

  • 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. ] [ Designated as safety issue: Yes ]
    The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.

  • The Number of Transplants With a Negative Crossmatch at Transplant. [ Time Frame: Number of Transplants with a Negative Crossmatch. ] [ Designated as safety issue: No ]
    The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.


Enrollment: 45
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mycophenolate mofetil (CellCept)
    500mg - 1,000mg, taken PO, twice daily.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446459

Locations
United States, Washington
Universtiy of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Hoffmann-La Roche
Investigators
Principal Investigator: Connie L Davis, MD University of Washington
  More Information

Publications:

Responsible Party: Dr. Connie Davis, University of Washington
ClinicalTrials.gov Identifier: NCT00446459     History of Changes
Other Study ID Numbers: 24223-A, 03-7915-A
Study First Received: March 9, 2007
Results First Received: December 29, 2009
Last Updated: April 5, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
CellCept
Dialysis
Kidney
Renal
Nephropathy
Glomerulonephropathy
Immunosuppression
Allograft
Compatibility
HLA
PRA
Transplant
Sensitization
Antibodies
Diabetes
Hypertension
Transplantation, Kidney

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency
Diabetic Nephropathies
Kidney Failure, Chronic
Glomerulonephritis
Glomerulonephritis, IGA
Hypertension, Renal
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Renal Insufficiency, Chronic
Nephritis
Autoimmune Diseases
Immune System Diseases
Antibodies
Mycophenolate mofetil
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 30, 2014