A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients
Status unconfirmed · Phase 4
Conditions studied: Fibrillary Glomerulonephritis
In brief
A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy.
Key facts
- Study ID
- NCT05546047
- Run by
- NephroNet, Inc.
- People needed
- 34
- Starts
- 2019-03-14
- Expected to finish
- 2024-10-27
- Last updated by the study team
- 2022-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male/Female age > 18
- Biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization
- Stable Maximum Renin-Angiotensin-Aldosterone System inhibition times 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site Principal Investigator
- Estimated Glomerular Filtration Rate > 25 mls/min calculate by the Chronic Kidney Disease-EPI formula
- Protein/creatinine ratio > 2000 mg/gm 5) Note: If protein/creatinine less than 2000 mg/gm, a formal 24- hour urine collection for total protein can be performed. The total 24-hour protein will need to >/= 2000mg.
- Blood pressure targeted to < 140/90 at the time of randomization
- Patients with Monoclonal Gammopathy without history of myeloma will be eligible.
- Patients with monoclonal staining for fibrillary fibers will be excluded
- Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions
You may not qualify if…
- Patients with MGUS and history of myeloma will not be eligible
- Patients with active viral production of either hepatitis B or C as evidence by historical polymerase chain reaction test positive for active viral shedding
- HIV seropositivity
- Renal biopsy data with > 50% Interstitial Fibrosis
- Patient with active or a known history lymphoma
- Patients with insulin dependent diabetes mellitus will be excluded Note: patients with Type II diabetes mellitus that are well controlled without the need for insulin will be eligible for the study.
- Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions.
- Patients receiving steroids, mycophenolate mofetil, cyclophosphamide, Azathioprine or other immunosuppressive agent with 4 weeks of study randomization Note: Washout of these medications will be allowed at the screening visit
- Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization
Where it is running
- Stanford University — Stanford, California, United States
- University of Colorado Anschutz Medical Department of Medicine Division of Renal Diseases and Hypertension — Aurora, Colorado, United States
- Georgia Nephrology DBA Georgia Nephrology Research Institute — Lawrenceville, Georgia, United States
- Columbia University Research Dept of Nephrology — New York, New York, United States
- Northeast Clinical Research Center — Bethlehem, Pennsylvania, United States
Full record on ClinicalTrials.gov
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