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.
Clinical and histologic evidence of IgA predominant Lupus nephritis
Patients with greater than 50% glomerular senescence or cortical scarring on renal
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
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
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
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
Inability to comply with study and follow-up procedures.
18 Years and older
Accepts Healthy Volunteers