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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 : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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 will measure how much the protein level went down in their urine by using Acthar.


Condition or disease Intervention/treatment Phase
Idiopathic Focal Segmental Glomerulosclerosis Drug: Acthar 80 U 3x/week Other: Placebo Drug: Acthar 80 U 2x/week Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The trial has three periods with potentially different trial designs (based on remission status):

Period 1: (Baseline to Week 23) All participants, open-label Acthar

Period 2: (Starting Week 26)

  • Participants who did not achieve remission in Period 1 continue on open-label Acthar to Week 50 (followed by 2 weeks of tapering); they enter Period 3 at Week 52.
  • Participants who did achieve remission are randomized to take either Acthar or Placebo to Week 50. They enter Period 3 at Week 50.

Period 3: All participants have a 4-week safety follow-up (within 56 weeks)

Masking: Double (Participant, Investigator)
Masking Description: Participants and investigator were blinded only to randomized treatment during Period 2
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 : May 16, 2016
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : August 28, 2020


Arm Intervention/treatment
Period 1: Acthar Open-Label
Participants receive open-label treatment with Acthar 80 U 3x/week, tapering to 2x per week if needed
Drug: Acthar 80 U 3x/week
Acthar 80 U 3x/week
Other Name: Acthar Gel

Drug: Acthar 80 U 2x/week
Acthar 80 U 2x/week
Other Name: Acthar Gel

Active Comparator: Period 2: Randomized to Acthar
Participants receive Acthar 80 U 2x/week through Week 50
Drug: Acthar 80 U 2x/week
Acthar 80 U 2x/week
Other Name: Acthar Gel

Placebo Comparator: Period 2: Randomized to Placebo
Participants receive Placebo 2x/week through Week 50
Other: Placebo
Placebo 2x/week
Other Name: Matching Placebo

Period 2: Open-label Acthar
Participants continue open-label treatment with Acthar 80 U 3x/week through Week 50, followed by a 2-week tapering period (within 52 weeks)
Drug: Acthar 80 U 3x/week
Acthar 80 U 3x/week
Other Name: Acthar Gel

No Intervention: Period 3: Safety Follow-up
All participants receive no intervention during a 4-week safety follow-up period, so the study completion date for each participant is within 56 weeks



Primary Outcome Measures :
  1. Total protein in a 24-hour urine sample [ Time Frame: within 56 weeks ]
    Total protein is measured in 24-hour urine samples



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
Investigators
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Study Director: Clinical Team Leader Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02633046    
Other Study ID Numbers: MNK14224049
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt:
FSGS
primary FSGS
idiopathic FSGS
Additional relevant MeSH terms:
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Proteinuria
Glomerulosclerosis, Focal Segmental
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glomerulonephritis
Nephritis
Kidney Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs