Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
| Sponsors |
Lead Sponsor: Radboud University Collaborator: Dutch Kidney Foundation |
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| Source | Radboud University | ||||
| Brief Summary | 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. |
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| Overall Status | Completed | ||||
| Start Date | July 2008 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2010 | ||||
| Phase | Phase 2 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 20 | ||||
| Condition | |||||
| Intervention |
Intervention Type: Drug Intervention Name: tetracosactide hexacetaat Description: 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. Arm Group Label: 1 Other Name: Synacthen Depot, long-acting synthetic ACTH |
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| Eligibility |
Criteria:
Inclusion Criteria: - Biopsy-proven idiopathic membranous nephropathy. - Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine < 30 g/l - Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula) - High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min - Relative contra-indication for cyclophosphamide treatment: - fertility and wish for (future) family expanding - high age ( > 60 years) - former cyclophosphamide treatment - intolerance to cyclophosphamide Exclusion Criteria: - Clinical,biochemical or histological signs of any underlying systemic disease - Any infectious disease (including latent tuberculosis and/or latent amoebiasis) - Active gastric or duodenal ulcers - Pregnancy, lactation, inadequate contraceptives - Clinical signs of renal vein thrombosis - Asthma and /or any allergic conditions or hypersensitivity reactions - Allergic reaction to synthetic ACTH in the past Gender: All Minimum Age: 18 Years Maximum Age: 95 Years Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
Netherlands |
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| Verification Date |
December 2010 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||
| Condition Browse | |||||
| Number Of Arms | 1 | ||||
| Arm Group |
Label: 1 Type: Experimental Description: In this open-label study all patients included are treated in the experimental group. |
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| Acronym | ACTHiMeN | ||||
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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