Phase 2 N=11 Treatment

Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

Fibrillary Glomerulonephritis

Bottom Line

View on ClinicalTrials.gov: NCT02197767 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Change in 24 Hour Creatinine Clearance — 41.0 mL/min/SA — p=0.072

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in 24 Hour Creatinine Clearance	41.0	0.072
SECONDARY Change in Proteinuria	2589.8	0.068

Summary

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

Eligibility Criteria

Inclusion Criteria

Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years
Proteinuria >1 gram
Age > 18 years but 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 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 6.0% within 90 days prior to enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02197767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.