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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date January 7, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment [ Time Frame: 9 and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Official Title  ICMJE Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Membranous Nephropathy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
In this open-label study all patients included are treated in the experimental group.
Intervention: Drug: tetracosactide hexacetaat
Publications * van de Logt AE, Beerenhout CH, Brink HS, van de Kerkhof JJ, Wetzels JF, Hofstra JM. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study. PLoS One. 2015 Nov 12;10(11):e0142033. doi: 10.1371/journal.pone.0142033. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694863
Other Study ID Numbers  ICMJE 2008.1
ABR: NL22482.091.08
CMO: 2008/77
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Dutch Kidney Foundation
Investigators  ICMJE
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
PRS Account Radboud University
Verification Date December 2010

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