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

This Study is
No Longer Enrolling

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

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

Type of Study

Treatment

Locations

Renal Research Center
University of Colorado Hospital

Study ID

Protocol Number: 19-2902

More information available at ClinicalTrials.gov: NCT04080076

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