Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

— ACTHiMeN  

Official title:

Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694863
• Other study ID #: 2008.1
• Secondary ID: ABR: NL22482.091
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2008
• Last updated: January 4, 2013
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• tetracosactide 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.

Locations

Country	Name	City	State
Netherlands	Radboud University	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

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