Arnogene: A Phosphocalcic Study in Dialysis (ARNOGENE)

This study has been completed.

Sponsor:

Information provided by:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT00858260

First received: March 6, 2009

Last updated: September 3, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2009

Last Updated Date

September 3, 2009

Start Date ^ICMJE

November 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Assessing morbi-mortality based on Klotho variants [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00858260 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival and serum phosphocalcic parameters [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Arnogene: A Phosphocalcic Study in Dialysis

Official Title ^ICMJE

Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients

Brief Summary

Searching for high morbi-mortality risk Klotho variants in dialysis patients

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Searching for high morbi-mortality risk Klotho variants

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing maintenance dialysis since at leat three months

Condition ^ICMJE

Dialysis

Intervention ^ICMJE

Genetic: blood sample

Searching for Klotho variants in DNA

Study Group/Cohort (s)

hemodialysis patients

Adult patients undergoing maintenance dialysis since at leat three months

Intervention: Genetic: blood sample

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1200

Completion Date

February 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Every adult > 18 years old and treated by dialysis in centers located in the Rhone Alpes area in France.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00858260

Other Study ID Numbers ^ICMJE

2007.471/14

Has Data Monitoring Committee

Responsible Party

Pr Denis FOUQUE, Hospices Civils de Lyon

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	FOUQUE Denis, MD	Hospices Civils de Lyon
Principal Investigator:	LEGRAND Eric, MD	CH Annonay
Principal Investigator:	KAARASLAN Huseyin, MD	CH Bourgoin Jallieu
Principal Investigator:	ABOKASEM Ayman, MD	CH Chalon/saône
Principal Investigator:	LATAILLADE Claire Dominique, MD	CH Sallanches
Principal Investigator:	KUENTZ François, MD	Centre Dialyse eaux claires
Principal Investigator:	HACHACHE Toufic, MD	CHU Grenoble - La Tronche
Principal Investigator:	LEITIENNE Philippe, MD	Hospices Civils de Lyon
Principal Investigator:	ARKOUCHE Walid, MD	AURAL - Lyon
Principal Investigator:	HEYANI Ahmed, MD	CH MACON
Principal Investigator:	HANNOUN Jacques, MD	CH Villefranche/saône
Principal Investigator:	COMBARNOUS François, MD	Clinique du Tonkin VILLEURBANNE
Principal Investigator:	MAUREAUGANDRY Xavier, MD	AGDUC - Montélimar
Principal Investigator:	SIRAJEDINE Mohamed, MD	CH ROMANS/ISERE
Principal Investigator:	JEAN Ahmed, MD	Centre du Rein - Tassin la demi lune
Principal Investigator:	DENICOLA Cora, MD	Calydial - CH Viennes

Information Provided By

Hospices Civils de Lyon

Verification Date

September 2009

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

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