Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Condition: Progressive IgA Nephropathy; Proteinuria
MeSH terms: Kidney Diseases; Proteinuria; Glomerulonephritis, IGA
Intervention: ACTH (Acthar) Gel
Intervention description: Injected dose of 80 units subcutaneously twice weekly for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACTH; Acthar; IgA; Progressive; Nephropathy; renal function

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.
    

Eligibility 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 glomerular filtration rate (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,
             mycophenolate mofetil (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

          -  Aspartate Aminotransferase (AST) or Alanine Aminotransferase (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.