Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

NCT ID: NCT02197767

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-04-30

Brief Summary

This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.

Detailed Description

This is a Phase II, open-label pilot 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. Each patient will be treated with 2 intravenous infusions of rituximab 1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each participant will receive 4 infusions of rituximab.

Conditions

Fibrillary Glomerulonephritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rituximab

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.

Group Type: EXPERIMENTAL

rituximab

Intervention Type: DRUG

1000 mg infusion

Interventions

rituximab

1000 mg infusion

Intervention Type: DRUG

Other Intervention Names

Rituxan

Eligibility Criteria

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 (angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin-receptor blockers (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 glomerular filtration rate (GFR) > 25 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (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
• Absolute Neutrophil Count (ANC): > 1000/ mm3
• Adequate liver function, as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin < 2x upper limit or normal unless related to primary disease
• Negative HBsAg and anti-hepatitis B (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Stephen B. Erickson, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen B. Erickson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Erickson SB, Zand L, Nasr SH, Alexander MP, Leung N, Drosou ME, Fervenza FC. Treatment of fibrillary glomerulonephritis with rituximab: a 12-month pilot study. Nephrol Dial Transplant. 2021 Jan 1;36(1):104-110. doi: 10.1093/ndt/gfaa065.

Reference Type: DERIVED

PMID: 32617582 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-006694

Identifier Type: -

Identifier Source: org_study_id