Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00694863 |
Date of registration:
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09/06/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
ACTHiMeN |
Scientific title:
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Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study |
Date of first enrolment:
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July 2008 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00694863 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jack FM Wetzels, M.D.Ph.D. |
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Radboud University |
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Name:
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Julia M Hofstra, M.D. |
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Radboud University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
95 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Membranous Nephropathy
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Intervention(s)
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Drug: tetracosactide hexacetaat
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Primary Outcome(s)
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Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
[Time Frame: 9 months]
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Secondary Outcome(s)
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Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment
[Time Frame: 9 and 24 months]
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Secondary ID(s)
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CMO: 2008/77
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2008.1
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ABR: NL22482.091.08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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