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

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

This study is currently recruiting participants.

Verified by Radboud University, February 2009

First Received: June 9, 2008 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Radboud University Dutch Kidney Foundation
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00694863

Purpose

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.

Condition	Intervention	Phase
Idiopathic Membranous Nephropathy	Drug: tetracosactide hexacetaat	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Cosyntropin Corticotropin

U.S. FDA Resources

Further study details as provided by Radboud University:

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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 :
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694863

Contacts

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

Locations

Netherlands
Radboud University	Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Julia M Hofstra, M.D. +31 24 364761 J.Hofstra@nier.umcn.nl
Principal Investigator: Julia M Hofstra, M.D.

Sponsors and Collaborators

Radboud University

Dutch Kidney Foundation

Investigators

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

More Information

No publications provided

Responsible Party:	Department of Nephrology, Radboud University ( Prof.dr.J.F.M.Wetzels )
Study ID Numbers:	2008.1, ABR: NL22482.091.08, CMO: 2008/77
Study First Received:	June 9, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00694863 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:

high risk for ESRD
immunosuppressive treatment
membranous nephropathy
ACTH

Study placed in the following topic categories:

Glomerulonephritis
Renal Insufficiency
Autoimmune Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Glomerulonephritis, Membranous
Cosyntropin
Membranous Nephropathy, Idiopathic
Hormones

Immunosuppressive Agents
Adrenocorticotropic Hormone
Urologic Diseases
Nephritis
Zinc
Kidney Diseases
Adrenocorticotropin zinc
Kidney Failure

Additional relevant MeSH terms:

Glomerulonephritis
Renal Insufficiency
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Glomerulonephritis, Membranous
Cosyntropin

Hormones
Pharmacologic Actions
Adrenocorticotropic Hormone
Urologic Diseases
Nephritis
Kidney Diseases
Kidney Failure
Adrenocorticotropin zinc

ClinicalTrials.gov processed this record on July 02, 2009