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

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ClinicalTrials.gov Identifier: NCT00694863
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : January 7, 2013
Sponsor:
Collaborator:
Dutch Kidney Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Membranous Nephropathy Drug: tetracosactide hexacetaat Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Cosyntropin

Arm Intervention/treatment
Experimental: 1
In this open-label study all patients included are treated in the experimental group.
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment [ Time Frame: 9 and 24 months ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694863


Locations
Netherlands
Radboud University
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Dutch Kidney Foundation
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00694863     History of Changes
Other Study ID Numbers: 2008.1
ABR: NL22482.091.08
CMO: 2008/77
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: December 2010

Keywords provided by Radboud University:
high risk for ESRD
immunosuppressive treatment
membranous nephropathy
ACTH

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Cosyntropin
Adrenocorticotropin zinc
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs