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Trial · Interventional

CompletedPhase 2Registry data

Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

Short name ACTHiMeN

NCTNCT00694863 (opens ClinicalTrials.gov in a new tab)Other id2008.1Other idABR: NL22482.091.08Other idCMO: 2008/77
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Overview

Status
Completed
Phase
Phase 2
Enrollment
20 participants (actual)
Sponsor
Radboud University Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Netherlands

Start
Jul 2008
Primary completion
Dec 2010
Completion
Dec 2012
First posted
11 Jun 2008 (estimated)
Last update posted
7 Jan 2013 (estimated)
Conditions
Idiopathic Membranous Nephropathy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 2

    ACTHiMeN

    NCT00694863

    Jul 2008 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • tetracosactide hexacetaatDrug

Arms1

  • Experimental

    1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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 outcomes(1)

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

    Time frame · 9 and 24 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • Derivedvan 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. PMID 26562836

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 95 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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