Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Drug: tetracosactide hexacetaat


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In this open-label study all patients included are treated in the experimental group. | Drug: tetracosactide hexacetaat<br>* 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.<br>* Other names: Synacthen Depot, long-acting synthetic ACTH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment |  | 9 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH