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Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression

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ClinicalTrials.gov Identifier: NCT02282930
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Brief Summary:
This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.

Condition or disease Intervention/treatment Phase
Progressive IgA Nephropathy Proteinuria Drug: ACTH (Acthar) Gel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 22, 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: ACTH Gel
Injected does of 80 units subcutaneously twice weekly for 6 months.
Drug: ACTH (Acthar) Gel
Injected dose of 80 units subcutaneously twice weekly for 6 months.




Primary Outcome Measures :
  1. Achieving Complete or Partial Response [ Time Frame: 12 Months ]

    Complete Response:

    <300 mg proteinuria/24 hours No greater than a 10% reduction in GFR as determined by quantified creatinine clearance.

    Partial Response:

    >50% reduction in 24 hour proteinuria No greater than a 25% reduction in baseline GFR as quantified creatinine clearance.

    No Response:

    A < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels will be considered no response.

    A greater than a 25% reduction in baseline GFR as quantified creatinine clearance.



Secondary Outcome Measures :
  1. Exploratory (Improvement in hematuria) [ Time Frame: 12 Months ]
    Improvement in hematuria. Categorical: <3 rbc/hpf; up to 20 rbc/hpf; 20 to 50; 50 to 100; >100 rbc/hpf



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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:

  • Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months.
  • Quantified 24h creatinine clearance > 30 ml/min/1.73m2.
  • Blood pressure < 130/80 mmHg at > 75% of the readings.
  • Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study.
  • Patient must be able to receive injections to be enrolled in the study.
  • Patient must have a kidney biopsy slide on file - that can be sent to Mayo Clinic.

Exclusion:

  • Clinical and histologic evidence of IgA predominant Lupus nephritis
  • Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy.
  • Serum Cr > 3.0 mg/dL or creatinine clearance GFR < 30 ml/min at the time of screening
  • Patients with history of Crohn's disease or Celiac Sprue
  • Clinical evidence of cirrhosis, chronic active liver disease.
  • Known infection with hepatitis B, hepatitis C, or HIV (Patients will be serologically screened prior to study entry (if the rest has been completed in the last two years, the patient will not have to undergo additional testing).
  • Active systemic infection with bacterial, viral, fungal, or mycobacterial or atypical mycobacterial infections (excluding fungal infections of nail beds).
  • Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
  • Positive pregnancy test or breast feeding at time of study entry (urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or patients unwilling to comply with contraceptive measures as outlined above.
  • Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the past 3 months.
  • Patients who had received immunosuppressive therapy including cyclophosphamide, MMF, cyclosporine, tacrolimus or azathioprine in the last 6 months.
  • Current or recent (within 30 days) exposure to any investigational drug.
  • Patients having received a live vaccine within 28 days of study enrollment.
  • Hemoglobin: < 8.5 gm/dL
  • Platelets: < 100,000/mm
  • AST or ALT > 2.5 x Upper Limit of Normal
  • Patients with anaphylaxis and/or known allergic reactions to ACTH
  • Previous Treatment with ACTH
  • History of drug, alcohol, or chemical abuse within 6 months prior to screening
  • Concomitant or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of psychiatric disorder that would interfere with normal participation in this protocol.
  • Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
  • Inability to comply with study and follow-up procedures.

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): NCT02282930


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Mayo Clinic
Mallinckrodt
Investigators
Principal Investigator: Fernando Fervenza, MD, PhD Mayo Clinic

Responsible Party: Fernando Fervenza, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02282930     History of Changes
Other Study ID Numbers: 14-006965
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Keywords provided by Fernando Fervenza, Mayo Clinic:
ACTH
Acthar
IgA
Progressive
Nephropathy
renal function

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