Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

NCT02197767 | Completed Phase 2 Results

• 1 other identifier: 13-006694
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrillary Glomerulonephritis

Keywords

fibrillary glomerulonephritis; rituximab; Rituxan; MabThera; Zytux™

Outcome Measures

Primary Outcomes (1)

• Change in 24 Hour Creatinine Clearance

  Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).

  Day 0, Day 365

Secondary Outcomes (1)

• Change in Proteinuria

  Day 0, Day 365

Study Arms (1)

rituximab

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.

Drug: rituximab

Interventions

rituximab DRUG

1000 mg infusion

Also known as: Rituxan

rituximab

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 32617582 DERIVED

MeSH Terms

Interventions

Rituximab

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: Dr. Stephen B. Erickson
• Organization: Mayo Clinic

Erickson.Stephen@mayo.edu

507-284-4083

Study Officials

• Stephen B. Erickson, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 23, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 6, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-01

Locations

US (1)