Status:
COMPLETED
Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Mallinckrodt
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced ...
Eligibility Criteria
Inclusion
- Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
- Age \> 18 years.
- Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
- Proteinuria of \>4.0 on a 24-hour urine collection.
- Estimated GFR \>40 ml/min/1.73m2 while taking ACEI/ARB therapy.
Exclusion
- Age \<18 years.
- Estimated GFR \<40 ml/min/1.73m2, or serum creatinine \>2.0 mg/dl.
- Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
- Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for \>1 month, and alkylating agents or rituximab for \>6 months.
- Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
- Patients with active infections or secondary causes of MN.
- Type 1 or 2 diabetes mellitus.
- Pregnancy or nursing.
- Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00805753
Start Date
January 1 2009
End Date
September 1 2014
Last Update
October 13 2014
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Toronto
Toronto, Ontario, Canada, M5R 0A3