Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2008

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00694863 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Idiopathic Membranous Nephropathy

Intervention ^ICMJE

Drug: tetracosactide hexacetaat

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2011 (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 :
1. fertility and wish for (future) family expanding
2. high age ( > 60 years)
3. former cyclophosphamide treatment
4. 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Julia M Hofstra, M.D.	+31 24 3614761	J.Hofstra@nier.umcn.nl
Contact: Jack FM Wetzels, M.D.Ph.D.	+31 24 3614761	J.Wetzels@nier.umcn.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00694863

Responsible Party

Prof.dr.J.F.M.Wetzels, Department of Nephrology, Radboud University

Study ID Numbers ^ICMJE

2008.1, ABR: NL22482.091.08, CMO: 2008/77

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

Information Provided By

Radboud University

Verification Date

February 2009

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