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A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy

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Disease Information

Descriptive Information
Brief Title † A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy
Official Title † A Dose-finding Pilot Study of ACTH (Adrenocorticotropic Hormone) on the Proteinuria and Serum Lipoprotein Profile in Patients With Idiopathic Membranous Nephropathy (MN)
Brief Summary Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus or the filter that removes toxins from the blood. Damage to the membrane that separates blood from urine results in loss of protein into the urine (proteinuria) and in some cases loss of kidney function.There is no standard specific treatment for MN. ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated patients with renal disease and in hemodialysis patients Some studies suggest that prolonged synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN, more extensive randomized studies with longer follow-up are needed before therapeutic recommendations can be made. We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN.
Detailed Description
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † change in proteinuria from baseline to value at 3 months .
Secondary Outcome Measure † Complete Remission(CR) or Partial Remission (PR) at 3 months
Condition † Glomerulonephritis
Intervention † DrugAdrenocorticotrophic hormone ACTH
Study Arms / Comparison Groups ACTH (HP Acthar gel) 40 units ACTH (HP Acthar gel) 80 units
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 10
Start Date † February 2010
Completion Date February 2013
Primary Completion Date January 2013
Eligibility Criteria † Inclusion Criteria:• Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization. - 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 (BP 75% of the readings). Patients with documented evidence of >3 months treatment with maximal Ang II blockade, target BP (BP 75% of the readings) and who remain with proteinuria >4.0g/24h may enter the ACTH phase of the study without the need to have the run-in/conservative phase of the study. - Proteinuria as measured by Uprot/Ucr > 4.0 on a spot sample aliquot from a 24-hour urine collection. The choice of Uprot/UCr is in accord with recent NKF-CKD guidelines.[9] - Estimated GFR ≥ 40 ml/min/1.73m2 while taking ACEI/ARB therapy. The GFR will be estimated using the 4 variable MDRD equation as published in the NKF-CKD guidelines.[9] The same NKF-CKD guidelines also promote the use of estimated GFR (GFRest) values rather than serum creatinine levels or CrCl measurements as the preferred non-invasive method of determining glomerular filtration rates.[9] Exclusion Criteria:• Age 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 (e.g. hepatitis B, SLE, medications, malignancies). Testing for HIV, Hepatitis B and C should have occurred
Gender All
Ages 18 Years - 72 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT01093157
Organization ID 08-006328-GN
Secondary IDs †† Health Canada
Responsible Party Sponsor
Study Sponsor † University Health Network, Toronto
Collaborators †† Mallinckrodt
Investigators † Principal Investigator: Daniel Cattran, M.D, University Health Network, Toronto
Information Provided By
Verification Date January 2013
First Received Date † March 24, 2010
Last Updated Date May 2, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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