Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy - Full Text View

Sponsor:	Radboud University
Collaborator:	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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

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 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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. Other Name: Synacthen Depot, long-acting synthetic ACTH

Eligibility

Ages Eligible for Study:	18 Years to 95 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:
- 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

Contacts and Locations

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

Locations

Netherlands
Radboud University
Nijmegen, Netherlands, 6500 HB

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:	Prof.dr.J.F.M.Wetzels, Department of Nephrology, Radboud University
ClinicalTrials.gov Identifier:	NCT00694863 History of Changes
Other Study ID Numbers:	2008.1, ABR: NL22482.091.08, CMO: 2008/77
Study First Received:	June 9, 2008
Last Updated:	January 4, 2011
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

Additional relevant MeSH terms:

Glomerulonephritis, Membranous
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Cosyntropin

Adrenocorticotropin zinc
Beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012