A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients
NCT ID: NCT05546047
Last Updated: 2022-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
34 participants
INTERVENTIONAL
2019-03-14
2024-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with Acthar gel
Group 1 - (17 patients) Acthar gel 80 units 2 times a week alone for 12 months of therapy.
Acthar Gel 80 UNT/ML Injectable Solution
Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus
Treatment with combination Acthar gel and Tacrolimus therapy
Group 2 - (17 patients) Acthar get 80 units 2 times a week plus oral Tacrolimus 1.0 mg two times a day titrated to trough Tacrolimus levels between 4-6 ng/ml
Acthar Gel 80 UNT/ML Injectable Solution
Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus
Interventions
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Acthar Gel 80 UNT/ML Injectable Solution
Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
NephroNet, Inc.
OTHER
Responsible Party
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Principal Investigators
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Jeremy Whitson, BS
Role: STUDY_DIRECTOR
NephroNet, Inc.
James Tumlin, MD
Role: PRINCIPAL_INVESTIGATOR
NephroNet, Inc.
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NN-002
Identifier Type: -
Identifier Source: org_study_id