Rituximab to Prevent Recurrence of Proteinuria

NCT01164098 | Terminated Phase 3 Results

• 2 other identifiers: 201004981R01DK090316-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

FSGS; Proteinuria

Outcome Measures

Primary Outcomes (1)

• Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.

  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.

  between post-transplant day 3 and day 30

Secondary Outcomes (2)

• Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12

  Post-Transplant Months 3-12

• Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)

  12 months post-transplant

Study Arms (2)

Rituximab

ACTIVE COMPARATOR

Participants will receive Rituximab post within 24 of Kidney Transplant

Drug: Rituximab

No rituximab

NO INTERVENTION

Participants will not receive Rituximab within 24 hours of Kidney Transplant

Interventions

Rituximab DRUG

Induction therapy

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been fully informed and has signed a dated IRB-approval informed consent form.
• Age 7-65 years.
• 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.

You may not qualify if:

• 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 gastro-intestinal 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.

Sponsors & Collaborators

• George W. Burke: lead
• Genentech, Inc.: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Proteinuria

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: George W. Burke, M.D.
• Organization: University of Miami

gburke@med.miami.edu

3053555315

Study Officials

• Alessia Fornoni, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• George W. Burke, M.D.

  University of Miami

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: February 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-09

Locations

US (1)