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

NCT05546047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-10-31

No results posted yet for this study

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.

Conditions

  • Fibrillary Glomerulonephritis

Interventions

DRUG

Acthar Gel 80 UNT/ML Injectable Solution

Follow up and observation for 12 months off Acthar gel or Acthar gel and Tacrolimus

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • NephroNet, Inc.

    lead OTHER

Principal Investigators

  • Jeremy Whitson, BS · NephroNet, Inc.

  • James Tumlin, MD · NephroNet, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2023-10-27
Completion
2024-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546047 on ClinicalTrials.gov