NCT05546047

A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: NephroNet, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 will be a multi-center, prospective, randomized, open-labeled intervention trial of 34 patients randomized to 52 weeks of ACTHar gel alone or Acthar gel plus oral Tacrolimus.

Conditions

• Fibrillary Glomerulonephritis

Interventions

Type	Name	Description
DRUG	Acthar Gel 80 UNT/ML Injectable Solution	Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus

Timeline

• Start date: 2019-03-14
• Primary completion: 2023-10-27
• Completion: 2024-10-27
• First posted: 2022-09-19
• Last updated: 2022-10-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study