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Rituximab to Prevent Recurrence of Proteinuria

This study has suspended participant recruitment.
(PI requested to put the study on hold.)
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
ClinicalTrials.gov Identifier:
NCT01164098
First received: July 15, 2010
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
FSGS
Proteinuria
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • The percentage of patients who develop nephrotic range proteinuria will be compared between the two treatment arms using an intent-to-treat approach. [ Time Frame: between post transplant day 3 and day 30 ] [ Designated as safety issue: Yes ]
    Primary outcome.


Secondary Outcome Measures:
  • Characterize regulation of SMPDL-3b/ASMase in recurrence FSGS [ Time Frame: from day 1 to 12 months ] [ Designated as safety issue: Yes ]
    Evaluate if sera of patients with recurrent disease affect podocyte function and survival


Enrollment: 43
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
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.
  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: NCT01164098

Locations
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
Principal Investigator: Alessia Fornoni, M.D. University of Miami
Study Director: George W. Burke, M.D. University of Miami
  More Information

Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01164098     History of Changes
Other Study ID Numbers: 20100498  1R01DK090316-01A1 
Study First Received: July 15, 2010
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Recurrence
Proteinuria
Disease Attributes
Pathologic Processes
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2016