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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

Study category: Kidney Disease & Hypertension

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Description

Each patient will undergo 12 months of treatment with 17 patients randomized to ACTHar gel alone (17 patients) or to ACTHar gel plus oral Tacrolimus (17 patients) Year 2: Follow up and observation for 12 months OFF ACTHar gel or ACTHar gel and Tacrolimus

Details
Age

Adult

Eligibility

Inclusion Criteria: 1) Male/Female age > 18 2) Biopsy proven Fibrillary GN within 3 years of study randomization

Detailed Eligibility: Inclusion Criteria: 1. Stable Maximum RAAS inhibition X 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site PI 2. eGFR > 25 mls/min calculate by the CKD-EPI formula 3. UP/Cr ratio > 2000 mg/gm 4. Blood pressure targeted to < 140/90 at the time of randomization Exclusion Criteria; 1. Patients with MGUS and history of myeloma WILL NOT be eligible 2. Patients with active viral production of either hepatitis B or C as evidence by historical PCR test positive for active viral shedding 3. HIV seropositivity 4. Renal biopsy data with > 50% Interstitial Fibrosis 5. Patient with active or a known history lymphoma 6. 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. 7. Patients with Type II non-insulin dependent diabetes WILL be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions. 8. Patients receiving steroids, MMF, cyclophosphamide, Azathioprine or other immunosuppressive agent with 4 weeks of study randomization Note: Washout of these medications will be allowed at the screening visit 9. Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Treatment

Locations

Renal Research Center
University of Colorado Hospital

Principal Investigator
Amber Podoll

Amber Podoll

Study ID

Protocol Number: 19-2902

More information available at ClinicalTrials.gov: NCT04080076

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