Phase 2
Completed N=11
Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
Fibrillary Glomerulonephritis
Source: ClinicalTrials.gov NCT02197767 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Change in 24 Hour Creatinine Clearance — 41.0 mL/min/SA — p=0.072
Summary
This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.
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 |
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
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. Informational only — not medical advice.