NCT00694863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 7, 2013

Status Verified

December 1, 2010

Enrollment Period

2.4 years

First QC Date

June 9, 2008

Last Update Submit

January 4, 2013

Conditions

Idiopathic Membranous Nephropathy

Keywords

high risk for ESRDimmunosuppressive treatmentmembranous nephropathyACTH

Outcome Measures

Primary Outcomes (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.

    9 months

Secondary Outcomes (1)

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

    9 and 24 months

Study Arms (1)

1

EXPERIMENTAL

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

Drug: tetracosactide hexacetaat

Interventions

tetracosactide hexacetaatDRUG

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.

Also known as: Synacthen Depot, long-acting synthetic ACTH
1

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26562836DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

adrenocorticotropin zinc

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jack FM Wetzels, M.D.Ph.D.

    Department of Nephrology, Radboud University

    STUDY DIRECTOR

  • Julia M Hofstra, M.D.

    Department of Nephrology, Radboud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

January 7, 2013

Record last verified: 2010-12

Locations

NL(1)