Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy (ACTHiMeN)

This study has been completed.
Sponsor:
Collaborator:
Dutch Kidney Foundation
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00694863
First received: June 9, 2008
Last updated: January 4, 2013
Last verified: December 2010

June 9, 2008
January 4, 2013
July 2008
December 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00694863 on ClinicalTrials.gov Archive Site
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment [ Time Frame: 9 and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Membranous Nephropathy
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.
Other Name: Synacthen Depot, long-acting synthetic ACTH
Experimental: 1
In this open-label study all patients included are treated in the experimental group.
Intervention: Drug: tetracosactide hexacetaat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00694863
2008.1, ABR: NL22482.091.08, CMO: 2008/77
No
Radboud University
Radboud University
Dutch Kidney Foundation
Study Director: Jack FM Wetzels, M.D.Ph.D. Department of Nephrology, Radboud University
Principal Investigator: Julia M Hofstra, M.D. Department of Nephrology, Radboud University
Radboud University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP