Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Idiopathic Membranous Nephropathy
 Drug: tetracosactide hexacetaat
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00694863     History of Changes
Other Study ID Numbers: 2008.1, ABR: NL22482.091.08, CMO: 2008/77
Study First Received: June 9, 2008
Last Updated: January 4, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Cosyntropin
 Adrenocorticotropin zinc
Beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013