Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

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 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) 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.