Clinical trial NCT02633046: Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Official title: Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Focal Segmental Glomerulosclerosis
Keywords: FSGS
primary FSGS
idiopathic FSGS
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: within 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami Lakes
country: United States
facility: VERITAS Research Corp
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research Corp
state: Florida
city: Lawrenceville
country: United States
facility: GA Nephrology
state: Georgia
city: Hinsdale
country: United States
facility: NANI Research
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Research Foundation, Inc.
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation, Baton Rouge
state: Louisiana
city: Las Vegas
country: United States
facility: NKDHC Medical Research Services, LLC
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine-Mt. Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Amarillo
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: Dallas
country: United States
facility: Texas Kidney Institute (Neprhotex Research Group)
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Wisconsin Dialysis Institute
state: Wisconsin
city: Junín
country: Argentina
facility: Centro de Salud Renal Junín SRL
state: BA
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas
state: BA
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: Gosford
country: Australia
facility: Renal Research Group
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospita
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hopital - Western Health
state: Victoria
city: Temuco
country: Chile
facility: Hospital Dr. Hernán Henríquez Aravena
state: IX Region
city: Santiago
country: Chile
facility: Clinica Davila
state: RM
city: Cuernavaca
country: Mexico
facility: Investigación Nefrológica SC
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital y Clínica OCA S.A de C.V
state: Nuevo Leon
city: San Martin de Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia
state: Lima
city: Lima Lima
country: Peru
facility: Hospital Nacional Hospital Maria Auxiliadora
city: Lima
country: Peru
facility: Hospital Nacional Alberto Sabogal
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: İstanbul
country: Turkey
facility: Şişli Etfal Hamidiye Training and Research Hospital
state: Sisli
city: İstanbul
country: Turkey
facility: İstanbul University Faculty of Medicine
state: Topkapi
city: Ankara
country: Turkey
facility: Ankara NumuneTraining and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
city: İstanbul
country: Turkey
facility: İstanbul University Faculty of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Medicine
city: Maltepe
country: Turkey
facility: Marmara University Faculty of Medicine
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
citation: 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.