Rituximab to Prevent Recurrence of Proteinuria

NCT ID: NCT01164098

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-10-31

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.

Detailed Description

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

Conditions

FSGS; Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

Participants will receive Rituximab post within 24 of Kidney Transplant

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Induction therapy

No rituximab

Participants will not receive Rituximab within 24 hours of Kidney Transplant

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rituximab

Induction therapy

Intervention Type: DRUG

Other Intervention Names

Rituxan

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

George W. Burke

OTHER

Sponsor Role: lead

Responsible Party

George W. Burke

Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alessia Fornoni, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

George W. Burke, M.D.

Role: STUDY_DIRECTOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

1R01DK090316-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20100498

Identifier Type: -

Identifier Source: org_study_id