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

Sponsors

Lead Sponsor: Radboud University

Collaborator: Dutch Kidney Foundation

Source Radboud University
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.

Overall Status Completed
Start Date July 2008
Completion Date December 2012
Primary Completion Date December 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
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 Outcome
Measure Time Frame
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment 9 and 24 months
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: tetracosactide hexacetaat

Description: 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.

Arm Group Label: 1

Other Name: Synacthen Depot, long-acting synthetic ACTH

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Radboud University
Location Countries

Netherlands

Verification Date

December 2010

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 1

Type: Experimental

Description: In this open-label study all patients included are treated in the experimental group.

Acronym ACTHiMeN
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov