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Acthar on Proteinuria in IgA Nephropathy Patients

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ClinicalTrials.gov Identifier: NCT02382523
Recruitment Status : Withdrawn (There were no subjects enrolled locally on this study since it opened. Local IRB closure has been requested.)
First Posted : March 6, 2015
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
David Sheikh-Hamad, Baylor College of Medicine

Brief Summary:

IgA nephropathy occurs when IgA—a protein that helps the body fight infections—settles in the kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine. Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage. Current treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE) inhibitor medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the angiotensin converting enzyme so that blood vessels can be relaxed.

This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely given for high blood pressure).

In previous clinical studies, some subjects with IgA nephropathy have experienced reductions in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug Administration (FDA) and used to treat patients with proteinuria.

The purpose is to study the safety and effectiveness of the study drug Acthar given at different doses.


Condition or disease Intervention/treatment Phase
IgA Nephropathy Proteinuria Drug: Acthar 80 unit injection Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria
Study Start Date : February 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Acthar injection 2 times per week
Acthar 80 unit injection 2 times a week
Drug: Acthar 80 unit injection

Subjects not responding after 3 months of therapy (increasing creatinine; proteinuria not lower by 30%), will continue therapy at a dose 120 U SC x2/wk. Treatment will be discontinued if improvement is not observed 6 months after initiation of therapy.

If partial remission is achieved with Acthar 80 U SC x2/wk or x3/wk then Acthar will be increased to 120 U SCx2/wk; if remission is achieved, treatment will be continued at this dose for a total of 12 months; otherwise, if response is not observed after 3 months of treatment with the higher dose, we will resume therapy with the original dose/schedule. We will check anti-ACTH antibodies in non-responders.

If relapse occurs during the follow-up period, a 6 month treatment with Acthar at 120 U SC x2/wk will be started (not for partial responders), and the response will be assessed.

Other Name: H.P. Acthar gel

Experimental: Acthar injection 3 times per week
Acthar 80 unit injection 3 times a week
Drug: Acthar 80 unit injection

Subjects not responding after 3 months of therapy (increasing creatinine; proteinuria not lower by 30%), will continue therapy at a dose 120 U SC x2/wk. Treatment will be discontinued if improvement is not observed 6 months after initiation of therapy.

If partial remission is achieved with Acthar 80 U SC x2/wk or x3/wk then Acthar will be increased to 120 U SCx2/wk; if remission is achieved, treatment will be continued at this dose for a total of 12 months; otherwise, if response is not observed after 3 months of treatment with the higher dose, we will resume therapy with the original dose/schedule. We will check anti-ACTH antibodies in non-responders.

If relapse occurs during the follow-up period, a 6 month treatment with Acthar at 120 U SC x2/wk will be started (not for partial responders), and the response will be assessed.

Other Name: H.P. Acthar gel




Primary Outcome Measures :
  1. To assess final protein/creatinine ratio [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of Inflammatory cells- change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  2. Percent of fibrosis (measured by trichrome staining) - change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  3. IgA level - change from baseline to 12 months to assess final kidney histology, disease activity index, and disease status. [ Time Frame: 12 months ]
  4. Amount of sclerosed glomeruli - change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  5. Serum Creatinine - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  6. Albumin - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  7. Aldosterone - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  8. Cortisol - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  9. Lipid Profile - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  10. P/Cr - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]


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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:

  1. Signed informed consent prior to any study specific procedures
  2. Male and females aged 18 years and older
  3. BMI 40 kg/m2 or less
  4. History of nephrotic syndrome due to IgA (confirmed from renal biopsy performed within last 5 years)
  5. Protein to creatinine (PCR) ratio 2.5 g/g or more (spot urine)
  6. Estimated GFR (eGFR) greater than 30 mL/min/1.73/m2 (as calculated using the abbreviated Modification of Diet in Renal Disease [MDRD] equation as per http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm).
  7. Any prior course of therapy with (but not within the last 3 months): steroids, cyclophosphamide, chlorambucil, cyclosporine or tacrolimus ). If, after f/u period, it was determined that subject did not achieve a complete or partial response, subject will be eligible for this study.
  8. Antihypertensive treatment including use of Angiotensin-converting enzyme inhibitors (ACEI) and/or Angiotensin receptor blockers (ARB):

    • Unless there is a history of intolerance to ACEI or ARB therapy, the subject must be treated with at least one of these agents,
    • Treatment with ACEI and/or ARB for 3 months or more prior to Visit 1, with stable maintenance dose(s) for 30 days or more prior to Visit 1,
    • If treated with other antihypertensive therapies, treatment duration of 30 days or more and stable maintenance dose for 7 days or more prior to Visit 1; and
  9. Blood pressure determined by the average of 3 or more seated readings taken 5 minutes or more apart at Visit 1:

    • Mean systolic blood pressure 140 mmHg or less and
    • Mean diastolic blood pressure 80 mmHg or less.
  10. Subjects must have the following laboratory results for study inclusion:

    • Hemoglobin 9 g/dL or more
    • Platelets 100 X 10^3 cells/mu-L
    • AST 2x ULN or less
    • ALT 2x ULN or less
    • Total bilirubin 2x ULN or less
    • HgbA1c less than 6.5%

Exclusion Criteria:

  1. Inability or refusal to give informed consent
  2. Unwillingness to receive or intolerant of SC injections of study medication
  3. Use of disease modifying agent within "delayed effect" 1 month of Visit 1 with: glucorticoids, cyclophosphamide, cyclosporine, cellcept
  4. Therapies and/or medications:

    • History of previous use of Acthar for treatment of nephrotic syndrome
    • Prior sensitivity to Acthar or other porcine protein products
    • Planned treatment with live or live attenuated vaccines once enrolled in the study
  5. Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within 1 month prior to Visit 1 (use of topical, inhaled, or intra-articular corticosteroids is allowed)
  6. Planned treatment with live or live attenuated vaccines once enrolled in the study.
  7. Contraindication to Acthar per Prescribing Information*
  8. For the purpose of this study: history of peptic ulcer is defined as 6 months or less prior to Visit 1.
  9. Renal target disease exclusions*
  10. Out of control or severe hypertension
  11. History of Systemic Lupus Erythematosus
  12. Uncontrolled Type 1 or type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
  13. History of Deep Vein Thrombosis (DVT) 6 months or less prior to Visit 1
  14. Presence of renal vein thrombosis:

    • Known current diagnosis by ultrasound, magnetic resonance imaging (MRI) or computed tomography scan
    • Signs or symptoms consistent with occurrence of acute renal vein thrombosis (hematuria in combination with flank pain and >30% unexplained acute rise in serum creatinine) with renal vein thrombosis confirmed by ultrasound, MRI or computed tomography scan
  15. Reproductive status:

    • Women who are pregnant
    • Women who are breastfeeding
    • Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the Investigator (women who are not of childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for 12 months or more prior to Visit 1
  16. Chronic active hepatitis C or B infection
  17. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation or who are known to be positive for human immunodeficiency virus
  18. Undergoing or have received therapy for solid tumor malignancy 5 years or less prior to Visit 1 (with the exception of treated and cured basal cell or treated and cured squamous cell carcinoma)
  19. Undergoing or have received therapy for blood malignancy 5 years or less from Visit 1
  20. Cardiovascular:

    • History of or active congestive heart failure (NYHA Functional Classification Class II through IV) on http://sscts.org/ClassificationHeartFailureNYHA.aspx

    OR

    • History of known dilated cardiomyopathy with left ventricular ejection fraction 30% or less

    OR

    • Occurrence of any of the following within 3 months of Visit 1:

      • Unstable angina
      • Myocardial infarction
      • Coronary artery bypass graft or percutaneous transluminal coronary angioplasty
      • Transient ischemic attack or cerebrovascular disease; or Unstable arrhythmia
  21. Administration of any other investigational medication or participation in an interventional clinical research study within 30 days of Visit 1
  22. Abuse of alcohol or other substance abuse within the 6 months prior to Visit 1 as determined by the Investigator
  23. Subject is a participating Investigator, study coordinator, employee of an Investigator, or immediate family member of any of the aforementioned

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): NCT02382523


Locations
United States, Texas
Harris Health System Smith Clinic or Ben Taub Hospital
Houston, Texas, United States, 77054
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: David Sheikh-Hamad, MD Baylor College of Medicine

Responsible Party: David Sheikh-Hamad, Professor (Medicine-Nephrology), Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02382523     History of Changes
Other Study ID Numbers: 32884 Acthar IgA Nephropathy
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by David Sheikh-Hamad, Baylor College of Medicine:
acthar
proteinuria
IgA nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Glomerulonephritis, IGA
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs