Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Mayo Clinic

Collaborator: Mallinckrodt

Stanford Investigator(s):

Intervention(s):

  • Drug: ACTH (Acthar) Gel

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kshama R Mehta, Ph.D
650-736-1822
Not Recruiting