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

Primary Purpose

Idiopathic Membranous Nephropathy

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
tetracosactide hexacetaat
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

In this open-label study all patients included are treated in the experimental group.

Outcomes

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.

Secondary Outcome Measures

Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment

Full Information

First Posted
June 9, 2008
Last Updated
January 4, 2013
Sponsor
Radboud University Medical Center
Collaborators
Dutch Kidney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00694863
Brief Title
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Acronym
ACTHiMeN
Official Title
Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Kidney Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
In this open-label study all patients included are treated in the experimental group.
Intervention Type
Drug
Intervention Name(s)
tetracosactide hexacetaat
Other Intervention Name(s)
Synacthen Depot, long-acting synthetic ACTH
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment
Time Frame
9 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack FM Wetzels, M.D.Ph.D.
Organizational Affiliation
Department of Nephrology, Radboud University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julia M Hofstra, M.D.
Organizational Affiliation
Department of Nephrology, Radboud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26562836
Citation
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.
Results Reference
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Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

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