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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633046
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : August 3, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Mallinckrodt ARD LLC )

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.


Condition or disease Intervention/treatment Phase
Idiopathic Focal Segmental Glomerulosclerosis Drug: Acthar Gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : August 27, 2020
Actual Study Completion Date : August 27, 2020


Arm Intervention/treatment
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 Name: Acthar




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: within 56 weeks ]

    Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with:

    1. death for any reason (all cause mortality)
    2. treatment emergent serious adverse events (TESAEs)
    3. any non-serious treatment emergent adverse events (TEAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633046


Locations
Show Show 47 study locations
Sponsors and Collaborators
Mallinckrodt ARD LLC
Investigators
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Study Director: Clinical Team Leader Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt ( Mallinckrodt ARD LLC ):
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Responsible Party: Mallinckrodt ARD LLC
ClinicalTrials.gov Identifier: NCT02633046    
Other Study ID Numbers: MNK14224049
First Posted: December 17, 2015    Key Record Dates
Results First Posted: August 3, 2021
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Mallinckrodt ( Mallinckrodt ARD LLC ):
FSGS
primary FSGS
idiopathic FSGS
Additional relevant MeSH terms:
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Proteinuria
Glomerulosclerosis, Focal Segmental
Urination Disorders
Urologic Diseases
Urological Manifestations
Glomerulonephritis
Nephritis
Kidney Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs