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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694863

Acronym

ACTHiMeN

Enrollment

Registered

2008-06-11

Start date

2008-07-31

Completion date

2012-12-31

Last updated

2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Membranous Nephropathy

Keywords

high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH

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.

Interventions

DRUGtetracosactide 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment	9 and 24 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026