Rituximab to Prevent Recurrence of Proteinuria

This study is currently recruiting participants.
Verified January 2014 by University of Miami
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
George W. Burke, University of Miami
ClinicalTrials.gov Identifier:
NCT01164098
First received: July 15, 2010
Last updated: January 28, 2014
Last verified: January 2014
  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
Kidney Transplant
Drug: Rituximab
Phase 2
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: 4 years ] [ Designated as safety issue: Yes ]
    Primary outcome.


Secondary Outcome Measures:
  • Determine podocyte SMPDL-3b expression in biopsies of patients with/without recurrence of FSGS. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rituximab Drug: Rituximab
Induction therapy
Other Name: Rituxan
No Intervention: No rituximab

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Females diagnosed with focal segmental glomerulosclerosis (FSGS).

Exclusion Criteria:

  • Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
  • 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.
  • Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
  • Patient is pregnant or lactating.
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
  • Patients with a defined genetic cause of FSGS, lymphoproliferative disorders or any malignant disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164098

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: George W. Burke, M.D.    305-355-5315    gburke@med.miami.edu   
Contact: Lois Hanson, R.N.    305-355-5315    lhanson2@med.miami.edu   
Principal Investigator: Alessia Fornoni, M.D.         
Sub-Investigator: George W. Burke, M.D.         
Sponsors and Collaborators
University of Miami
Genentech
Investigators
Principal Investigator: Alessia Fornoni, M.D. University of Miami
Study Director: George W. Burke, M.D. University of Miami
  More Information

No publications provided

Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01164098     History of Changes
Other Study ID Numbers: 20100498
Study First Received: July 15, 2010
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014