Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria (PODOCYTE)

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Focal Segmental Glomerulosclerosis
• Intervention / Treatment: Drug: Acthar Gel

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • BA
    • Junín, BA, Argentina, B6000GPB
      • Centro de Salud Renal Junín SRL
    • Mar del Plata, BA, Argentina, B7600FYK
      • Centro de Investigaciones Médicas
• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 3021
      • Renal Research Group
    • Liverpool, New South Wales, Australia, 3021
      • Liverpool Hospital
    • Westmead, New South Wales, Australia, 3021
      • Westmead Hospita
  • Queensland
    • Herston, Queensland, Australia, 3021
      • Royal Brisbane and Women's Hospital
  • Tasmania
    • Launceston, Tasmania, Australia, 3021
      • Launceston Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3021
      • The Alfred Hospital
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hopital - Western Health
• Chile
  • IX Region
    • Temuco, IX Region, Chile, 4781151
      • Hospital Dr. Hernan Henriquez Aravena
  • RM
    • Santiago, RM, Chile, 8340518
      • Clínica Dávila
• Mexico
  • Morelos
    • Cuernavaca, Morelos, Mexico, 64000
      • Investigación Nefrológica SC
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Hospital y Clínica OCA S.A de C.V
• Peru
  • Lima, Peru
    • Hospital Nacional Arzobispo Loayza
  • Lima, Peru
    • Hospital Nacional Alberto Sabogal
  • Lima Lima, Peru
    • Hospital Nacional Hospital Maria Auxiliadora
  • Lima
    • San Martin de Porres, Lima, Peru
      • Hospital Nacional Cayetano Heredia
• Turkey
  • Ankara, Turkey, 06340
    • Ankara Training and Research Hospital
  • Ankara, Turkey, 06100
    • Ankara NumuneTraining and Research Hospital
  • Kocaeli, Turkey, 41380
    • Kocaeli University Faculty of Medicine
  • Maltepe, Turkey, 34840
    • Marmara University Faculty of Medicine
  • Mersin, Turkey, 33000
    • Mersin University Faculty of Medicine
  • İstanbul, Turkey, 34098
    • Istanbul University Faculty of Medicine
  • Sisli
    • İstanbul, Sisli, Turkey, 034360
      • Şişli Etfal Hamidiye Training and Research Hospital
  • Topkapi
    • İstanbul, Topkapi, Turkey, 34093
      • Istanbul University Faculty of Medicine
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85712
      • AKDHC Medical Research Services, LLC
  • California
    • Chula Vista, California, United States, 91910
      • California Institute of Renal Research
    • Stanford, California, United States, 94305
      • Stanford University
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • VERITAS Research Corp
    • Tampa, Florida, United States, 33614
      • Genesis Clinical Research Corp
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • GA Nephrology
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • NANI Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Research Foundation, Inc.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Ochsner Clinic Foundation, Baton Rouge
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • NKDHC Medical Research Services, LLC
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine-Mt. Sinai
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Metrolina Nephrology Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Brookview Hills Research Associates, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Medical Center
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Physicians Company, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Tech University Health Science Center
    • Dallas, Texas, United States, 75231
      • Texas Kidney Institute (Neprhotex Research Group)
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Wisconsin Dialysis Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Potential participants must meet the following summary criteria for inclusion in the study:

• Is male or non-pregnant, non-lactating female
• Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria response with prior therapy
• Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker (or have documented intolerance), for at least 4 weeks before screening
• Has blood pressure no higher than 150/90 mmHg
• Meets all other inclusion criteria detailed in the protocol

Exclusion Criteria

Potential participants will not be eligible for the the study if they meet the following summary criteria:

• Has hepatitis B or C, tuberculosis, or other contraindication listed on the United States (US) Prescribing Information for Acthar
• Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection
• Has received specific treatments at exclusionary time points per protocol
• Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4 weeks before screening
• Meets any other exclusion criteria detailed in the protocol

• Has any other condition that might, per protocol or in the opinion of the investigator, compromise:

  1. the safety and well-being of the participant or their offspring
  2. the safety of study staff
  3. analysis of results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Acthar Gel; Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product (IMP).

Drug: Acthar Gel; Acthar Gel 80 U/mL solution for subcutaneous injection; Other Names: Acthar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with: death for any reason (all cause mortality); treatment emergent serious adverse events (TESAEs); any non-serious treatment emergent adverse events (TEAEs)	within 56 weeks

Collaborators and Investigators

• Sponsor: Mallinckrodt ARD LLC

Publications and helpful links

General Publications

• Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: FSGS; primary FSGS; idiopathic FSGS
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Nephritis; Glomerulonephritis; Proteinuria; Glomerulosclerosis, Focal Segmental; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone
• Other Study ID Numbers: MNK14224049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02633046) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.