Overview

This trial is active, not recruiting.

Condition fibrillary glomerulonephritis
Treatment rituximab
Phase phase 2
Target CD20
Sponsor Mayo Clinic
Collaborator Genentech, Inc.
Start date November 2014
End date April 2017
Trial size 11 participants
Trial identifier NCT02197767, 13-006694

Summary

Will use of Rituximab reduce proteinuria over a 12 month period and will there be preservation of kidney function with the use of this study drug?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.
rituximab Rituxan
After successful enrollment, patients will be treated with an infusion dose of rituximab at Day 1 and at Day 15. CD 20+ cell count will be drawn pre and post infusion at Day 1, Day 28, Day 181, and Day 365. Patients will be retreated with a second dose of rituximab at 6 months independently of CD 20+ cell count.

Primary Outcomes

Measure
Preservation of kidney function
time frame: 12 months

Secondary Outcomes

Measure
Reduction in proteinuria
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

Inclusion Criteria: Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years Proteinuria >1 gram Age > 18 years but < 80 years Adequately controlled blood pressure (BP<140/90 mmHg in >75% of the readings) for at least 3 months prior to enrollment with the use of ACEi and/or ARB, if tolerated. Women must be post- menopausal, surgically sterile or practicing a medically approved method of contraception Able and willing to give written informed consent and comply with the requirements of the study protocol Adequate renal function as indicated by estimated GFR > 25 mL/min using CKD/EPI formula or a quantified creatinine clearance >25 mL/min, and/or serum creatinine <3.0 mg/dL in the presence of ACEi/ARB therapy Adequate bone marrow function, as indicated by hemoglobin >7.0 gm/dL, white count >3.0 x 10(9), platelet count >100 x 10(9) Negative chest x-ray within one year Negative serum pregnancy test (for women of child bearing age) Normal organ function. Subject agrees to use an acceptable method of birth control during treatment and for twelve months after completion of treatment Subject has provided written informed consent Subject agrees to discontinue routine use of non-steroidal anti-inflammatory drugs ANC: > 1000/ mm3 (Absolute Neutrophil Count) Adequate liver function, as indicated by AST, ALT, alkaline phosphatase and total bilirubin < 2x upper limit or normal unless related to primary disease Negative HBsAg and anti-HBc lab values within 1 year of signing consent Exclusion Criteria: Pregnancy (determined by a serum pregnancy test for all women of childbearing potential within 7 days of treatment), or lactating. Inability to comply with study and/or follow-up procedures History of HIV (a documented positive lab value within one year of enrollment) Presence of active infection New York Heart Association Classification III or IV heart disease Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix History of psychiatric disorder At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to randomization At the Investigator's discretion, positive Hepatitis C serology Known history of diabetes mellitus or a Hemoglobin A1c result > 6.0% within 90 days prior to enrollment

Additional Information

Official title A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
Principal investigator Stephen B. Erickson, M.D.
Description This is a Phase II, open-label study to determine if the use of Rituximab reduces proteinuria over a 12 month period and is there preservation of kidney function with the use of this study drug. Aim 1) Preservation of kidney function at 12 months as defined by stable or improved 24 hour creatinine clearance. Aim 2) Reduction in proteinuria at 12 months & improved quality of life at 12 months validated by questionnaire.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.