Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446251
Recruitment Status : Completed
First Posted : March 12, 2007
Results First Posted : March 29, 2010
Last Update Posted : April 6, 2010
Genentech, Inc.
Information provided by:
University of Washington

Brief Summary:
This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal Drug: Rituximab Drug: Mycophenolate mofetil (MMF) Phase 2

Expanded Access : University of Washington has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Highly Sensitized Patients: Effects of Rituximab and Mycophenolate Mofetil (MMF) On Anti-Human Leukocyte Antigen (HLA) Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
Study Start Date : December 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Intervention Details:
  • Drug: Rituximab
    Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15).
    Other Name: Rituxan, Rituximab
  • Drug: Mycophenolate mofetil (MMF)
    Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.
    Other Name: mycophenolate mofetil, MMF, Cellcept

Primary Outcome Measures :
  1. The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion. [ Time Frame: Month 6 from start of study ]
    the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion

Secondary Outcome Measures :
  1. The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion. [ Time Frame: Month 12 from start of study ]
  2. The Number of Subjects With a Negative Crossmatch at the Time of Transplant. [ Time Frame: Month 12 from start of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age range 18 - 75, inclusive
  • Able and willing to give written informed consent and comply with the requirements of the study protocol
  • Outpatient status
  • Patients with a Panel of Reactive Antibodies (PRA) over 10% after an 8-month trial of MMF monotherapy
  • Patients with updated immunizations for tetanus, influenza, hepatitis B, pneumococcus
  • Patients with a negative purified protein derivative(PPD ) screen for tuberculosis (TB)within the last 6 months. If subject has a prior history of TB 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 and for twelve months (1 year) after completion of treatment.
  • Men must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
  • Liver enzymes ALT and AST less than 2 times the normal limit.

Exclusion Criteria:

  • Active infection
  • Receipt of live vaccine within 4 weeks prior to first infusion.
  • Previous treatment with rituximab (MabThera® / Rituxan®)
  • 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 hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, pregnant or breast-feeding, baseline leukopenia, white blood cell count (WBC) less than 4.0, thrombocytopenia (platelet count less than 100,000/mm) or difficult to treat anemia, a hematocrit chronically less than 32 on intravenous iron and EPO (erythropoietin) therapy, history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of psychiatric disorder
  • Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446251

Sponsors and Collaborators
University of Washington
Genentech, Inc.
Principal Investigator: Connie L Davis, MD University of Washington

Vieira CA, Agarwal A, Book BK, Sidner RA, Zeni T, Gebel HM, Roggero AL, Fineberg NA, Taber T, Kraus MA, Pescovitz MD. Rituxan for reduction of anti-HLA antibodies in patients awaiting renal transplantation. Am J Transplantation 2002;2:A870.

Responsible Party: Dr. Connie Davis, University of Washington Identifier: NCT00446251     History of Changes
Other Study ID Numbers: 25668-A
04-0927-A 05 ( Other Identifier: University of Washington HSD study number )
First Posted: March 12, 2007    Key Record Dates
Results First Posted: March 29, 2010
Last Update Posted: April 6, 2010
Last Verified: March 2010

Keywords provided by University of Washington:
Transplantation, Kidney

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Diabetic Nephropathies
Kidney Failure, Chronic
Glomerulonephritis, IGA
Hypertension, Renal
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Renal Insufficiency, Chronic
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors