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Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS (PODOCYTE)

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ClinicalTrials.gov Identifier: NCT02633046
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
Multicenter, multiple dose study to examine the effect of H.P. Acthar® Gel (repository corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A 2 Part Prospective Study of H.P. Acthar® Gel (PODOCYTE)
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Acthar 80 U 3x/week Open Label Treatment Period
Starting at Week 0-23, open label treatment with Acthar 80 U 3x/week.
Drug: Acthar 80 U 3x/week
Acthar 80 U 3x/week
Other Name: H.P. Acthar® Gel

Active Comparator: Acthar 80 U 2x/week
Starting at Week 26 for subjects who meet remission criteria at Week 23.
Drug: Acthar 80 U 2x/week
Acthar 80 U 2x/week
Other Name: H.P. Acthar® Gel

Placebo Comparator: Placebo 80 U 2x/week
Starting at Week 26 for subjects who meet remission criteria at Week 23.
Other: Placebo 80 U 2x/week
Placebo 80 U 2x/week

Acthar 80 U 3x/week Open Label Extension
Starting at Week 26 for subjects who do not achieve remission at Week 23, an additional 24 weeks of open label treatment with Acthar 80 U 3x/week will be available.
Drug: Acthar 80 U 3x/week
Acthar 80 U 3x/week
Other Name: H.P. Acthar® Gel




Primary Outcome Measures :
  1. Complete and partial remission of proteinuria at Week 24. [ Time Frame: 24 Weeks ]
    Number of subjects with complete remission (uPCR ≤ 300 mg/g) + number of subjects with partial remission (uPCR ≤ 3500 mg/g but >300 mg/g and 50% reduction from baseline) at Week 24 (Visit 8)



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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

Subjects must meet all of the following criteria for inclusion in the study at the Screening Visit/Visit 1 and the Baseline Visit/Visit 2:

  1. Must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date on the ICF.
  2. Must be at least 18 years of age at Screening Visit/Visit 1 and can be male or female.
  3. Female subjects must be of nonchildbearing potential (history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow in the 12 months prior to Screening Visit/Visit 1), or if of childbearing potential must be nonpregnant, nonlactating and agree to use effective contraception with a male partner throughout study participation and for 4 weeks after ending study participation. Acceptable forms of contraception include hormonal measures (oral contraceptive pills, contraceptive patch, contraceptive ring, injections), intrauterine devices, double barrier method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), and abstinence.
  4. Must have a history of primary FSGS confirmed by a renal biopsy.
  5. Must be willing to undergo a renal biopsy unless the most recent renal biopsy is within 3 years of the Screening Visit/Visit 1.
  6. Must have a total urine protein creatinine ratio (uPCR) greater than 3.0 mg/mg at Screening Visit/Visit 1.
  7. Must have an estimated glomerular filtration rate (eGFR) at least 30 mL/min/1.73 m2 at the Screening Visit/Visit 1 as calculated by the 4-variable modification of diet in renal disease (MDRD) study equation.
  8. Must have failed to achieve sustained CR or PR of proteinuria as determined by the investigator with at least 1 prior immunosuppressive therapy, or must have intolerance to at least 1 prior immunosuppressive therapy.
  9. Must have been treated with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to Screening Visit/Visit 1 and on stable maintenance dose(s) for at least 14 days prior to Screening Visit/Visit 1 and are expected to remain on that dose for the duration of the study or have a documented intolerance to ACEi or ARB with approval from the MM prior to enrollment. Subjects taking other antihypertensive medication(s), must be on a stable dose of for at least 4 weeks prior to the Screening Visit/Visit 1.
  10. Must have a mean systolic blood pressure no more than 150 mm Hg and a diastolic blood pressure of no more than 90 mm Hg determined by the average of at least 3 seated readings taken at least 5 minutes apart at Screening Visit/Visit 1 and at the Baseline Visit/Visit 2.
  11. Must be able to communicate effectively with study personnel.
  12. Must be able and willing to follow all protocol requirements and study restrictions.
  13. Must be able and willing to return for all study visits.

Exclusion Criteria

Subjects are ineligible for study participation if they meet any of the following criteria at the Screening Visit/Visit 1 or Baseline Visit/Visit 2:

  1. Is from a vulnerable population, as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB/IEC.
  2. Is unwilling to receive, or is intolerant of, subcutaneous injections.
  3. Has any history of use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to Acthar and Synacthen®).
  4. Has a history of sensitivity to ACTH preparations (including but not limited to Acthar and Synacthen).
  5. Has a history of sensitivity to porcine protein products.
  6. Has a body mass index (BMI) greater than 45 kg/m2 at Screening Visit/Visit 1.
  7. Has secondary FSGS, including but not limited to, obesity, known genetic cause, reduced kidney mass, Human Immunodeficiency Virus (HIV), intravenous heroin abuse, or sickle cell anemia.
  8. Cannot have failed to achieve sustained CR or PR of proteinuria, as determined by the investigator, on more than 2 prior immunosuppressive therapies with different mechanisms of action.
  9. Has had a renal biopsy demonstrating greater than 50% global glomerular sclerosis, or greater than 50% cortical interstitial fibrosis, or collapsing FSGS.
  10. Has any known contraindication(s) to Acthar including, but not limited to:
  11. Any known history of scleroderma, osteoporosis, or ocular herpes simplex.
  12. Any current uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
  13. Any current congestive heart failure (defined as New York Heart Association Functional Class III to IV).
  14. Peptic ulcer (within 6 months prior to Screening Visit/Visit 1).
  15. Recent major surgery (within 6 months prior to Screening Visit/Visit 1, renal biopsy is not considered an exclusionary surgical procedure).
  16. Has a history of chronic active hepatitis; acute or chronic hepatitis B; or acute or chronic hepatitis C.
  17. Has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.
  18. Has a clinically significant infection requiring intravenous administration of antibiotics and hospitalization in the 4 weeks prior to Screening Visit/Visit 1.
  19. Has known immune compromised status, including but not limited to, individuals who have undergone organ transplantation or who are known to be positive HIV.
  20. Has Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not exclusionary).
  21. Has had any of the following in the 12 weeks prior to Screening Visit 1/Visit 1: unstable angina confirmed by a cardiologist, myocardial infarction, coronary artery bypass graft, percutaneous trans-luminal coronary angioplasty, transient ischemic attack or cerebrovascular disease, unstable cardiac arrhythmia, or resuscitated sudden cardiac death.
  22. Has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to Screening Visit/Visit 1, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
  23. Has a diagnosis of, is undergoing therapy for, or has received therapy for a hematologic malignancy in the 5 years prior to Screening Visit/Visit 1.
  24. Has been treated with certain medications within specified timeframes prior to the Screening Visit/Visit 1 (Rituximab, Investigational treatment for FSGS, Intravenous/intramuscular corticosteroids,Therapeutic drug/device trial (except FSGS), Cyclophosphamide, Chronic oral, corticosteroids
  25. Has been treated with certain medications within specified timeframes prior to Baseline Visit/Visit 2 (Corticosteroids , Mycophenolate, Mofetil).
  26. Has current or recent (within 6 months of the Screening Visit/Visit 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnostic Criteria for Drug and Alcohol Abuse.
  27. Has any of the following laboratory abnormalities at the Screening Visit/Visit 1:

    • Hemoglobin less than 8.0 g/dL.
    • Platelets less than 50,000 cells/μL.
    • Absolute neutrophil count (ANC) greater than 1000 cells/μL.
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin greater than 2 times the upper limit of normal (ULN).
    • Glycosylated hemoglobin (HbA1c) greater than 6.5%.
    • Positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb).
    • Positive Hepatitis C virus antibody (HCV) and HCV polymerase chain reaction (PCR) at least 25 IU/mL (HCV PCR will be automatically analyzed if HCV is positive).
    • Positive or indeterminate interferon gamma release assay (IGRA).
  28. Has any other clinically significant disease, disorder or laboratory abnormality which, in the opinion of the investigator (by its nature or by being inadequately controlled), might put the patient at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study.

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


Contacts
Contact: Valerie Carvajal 800-556-3314 clinicaltrials@mnk.com

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Sponsors and Collaborators
Mallinckrodt

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02633046     History of Changes
Other Study ID Numbers: MNK14224049
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Mallinckrodt:
FSGS
primary FSGS
idiopathic FSGS

Additional relevant MeSH terms:
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