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Rituximab to Prevent Recurrence of Proteinuria

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: NCT01164098
Recruitment Status : Terminated (Voluntarily terminated by PI due to lack of feasibility.)
First Posted : July 16, 2010
Results First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
Genentech, Inc.
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
George W. Burke, University of Miami

Brief Summary:
The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.

Condition or disease Intervention/treatment Phase
FSGS Proteinuria Drug: Rituximab Phase 3

Detailed Description:
A total of 60 patients will be enrolled in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS
Study Start Date : February 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Active Comparator: Rituximab
Participants will receive Rituximab post within 24 of Kidney Transplant
Drug: Rituximab
Induction therapy
Other Name: Rituxan

No Intervention: No rituximab
Participants will not receive Rituximab within 24 hours of Kidney Transplant



Primary Outcome Measures :
  1. Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. [ Time Frame: between post-transplant day 3 and day 30 ]
    Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach.


Secondary Outcome Measures :
  1. Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 [ Time Frame: Post-Transplant Months 3-12 ]
    Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach.

  2. Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) [ Time Frame: 12 months post-transplant ]
    Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Patient has been fully informed and has signed a dated IRB-approval informed consent form.
  2. Age 7-65 years.
  3. Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not required once the physician confirms the diagnosis. Transcribed reports from referring physicians are also valid.

Exclusion:

  1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
  2. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
  3. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
  4. Patient is pregnant or lactating.
  5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
  6. Patients with a defined genetic cause of FSGS.

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 ClinicalTrials.gov identifier (NCT number): NCT01164098


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
George W. Burke
Genentech, Inc.
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Alessia Fornoni, M.D. University of Miami
Study Director: George W. Burke, M.D. University of Miami

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Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01164098    
Other Study ID Numbers: 20100498
1R01DK090316-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2010    Key Record Dates
Results First Posted: September 20, 2018
Last Update Posted: September 20, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Proteinuria
Recurrence
Disease Attributes
Pathologic Processes
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents