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Sponsors and Collaborators: |
Radboud University Dutch Kidney Foundation |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00694863 |
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Membranous Nephropathy |
Drug: tetracosactide hexacetaat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
In this open-label study all patients included are treated in the experimental group.
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Drug: tetracosactide hexacetaat
Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relative contra-indication for cyclophosphamide treatment :
Exclusion Criteria:
Contact: Julia M Hofstra, M.D. | +31 24 3614761 | J.Hofstra@nier.umcn.nl |
Contact: Jack FM Wetzels, M.D.Ph.D. | +31 24 3614761 | J.Wetzels@nier.umcn.nl |
Netherlands | |
Radboud University | |
Nijmegen, Netherlands, 6500 HB |
Study Director: | Jack FM Wetzels, M.D.Ph.D. | Department of Nephrology, Radboud University |
Principal Investigator: | Julia M Hofstra, M.D. | Department of Nephrology, Radboud University |
Responsible Party: | Department of Nephrology, Radboud University ( Prof.dr.J.F.M.Wetzels ) |
Study ID Numbers: | 2008.1, ABR: NL22482.091.08, CMO: 2008/77 |
Study First Received: | June 9, 2008 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00694863 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC) |
high risk for ESRD immunosuppressive treatment membranous nephropathy ACTH |
Glomerulonephritis Renal Insufficiency Autoimmune Diseases Glomerulonephritis, Membranous Cosyntropin Adrenocorticotropic Hormone Urologic Diseases |
Nephritis Zinc Kidney Diseases Membranous nephropathy, idiopathic Kidney Failure Adrenocorticotropin zinc |
Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |