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Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

NCT02633046 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-08-04

Study results available
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Summary

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney.

FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant.

Proteinuria means too much protein came through the kidneys into the urine.

If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat.

This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.

Conditions

  • Idiopathic Focal Segmental Glomerulosclerosis

Interventions

DRUG

Acthar Gel

Acthar Gel 80 U/mL solution for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt ARD LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2020-08-27
Completion
2020-08-27

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • Mexico
  • Peru
  • Turkey (Türkiye)

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 NCT02633046 on ClinicalTrials.gov