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. |
ClinicalTrials.gov Identifier: NCT00446251 |
Recruitment Status
:
Completed
First Posted
: March 12, 2007
Results First Posted
: March 29, 2010
Last Update Posted
: April 6, 2010
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal | Drug: Rituximab Drug: Mycophenolate mofetil (MMF) | Phase 2 |
University of Washington has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

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 |

-
Drug: Rituximab
- 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
- 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 ]
- The Number of Subjects With a Negative Crossmatch at the Time of Transplant. [ Time Frame: Month 12 from start of study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00446251
Principal Investigator: | Connie L Davis, MD | University of Washington |
Publications:
Responsible Party: | Dr. Connie Davis, University of Washington |
ClinicalTrials.gov 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:
Dialysis Kidney Renal Nephropathy Glomerulonephropathy Immunosuppression |
Graft Compatibility Transplant 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 Rituximab 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 |