Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Phase 2

Completed

• Conditions: Idiopathic Membranous Nephropathy
• Interventions: Drug: tetracosactide hexacetaat

• Registration Number: NCT00694863
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Study Start: 2008-07
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	tetracosactide hexacetaat	In this open-label study all patients included are treated in the experimental group.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Radboud University; 🇳🇱 Nijmegen, Netherlands