Rituximab to Prevent Recurrence of Proteinuria

Proteinuria Clinical Trial

Official title:

The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01164098
• Other study ID #: 20100498
• Secondary ID: 1R01DK090316-01A
• Status: Terminated
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: October 2016

Study information

• Verified date: September 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• FSGS
• Proteinuria
• Recurrence

Intervention

Drug:
• Rituximab
Induction therapy

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (4)

Lead Sponsor	Collaborator
George W. Burke	Genentech, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum of the Urine Protein/Creatinine Ratio Observed Between 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.	Post-Transplant Months 3-12
Secondary	Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)	Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula	12 months post-transplant