Idiopathic Membranous Nephropathy Clinical Trial
— ACTHiMeNOfficial title:
Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2012 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Dutch Kidney Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 9 months | Yes | |
Secondary | Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment | 9 and 24 months | No |
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