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Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression (Pre-HD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT00608998
First received: January 23, 2008
Last updated: March 28, 2011
Last verified: January 2008
  Purpose

The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.


Condition
Chronic Renal Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • description of osteoprotegerin levels according to chronic renal failure progression [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calcium score description according to chronic renal failure progression [ Time Frame: inclusion ] [ Designated as safety issue: No ]
  • osteoprotegerin description according to calcium score [ Time Frame: inclusion ] [ Designated as safety issue: No ]
  • relationship between cardiovascular risk factors and calcium score [ Time Frame: inclusion ] [ Designated as safety issue: No ]
  • relationship between cardiovascular risk factors and cardiovascular disease [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood white cells serum plasma urine


Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of this study is to appreciate the relationship between:

  • extension of coronary calcifications and chronic renal failure progression
  • extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
  • cardiovascular risk factors and coronary calcifications
  • cardiovascular risk factors and existence of cardiovascular diseases
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Patient who has signed the written consent form
  • Patient aged > 18 and < 90 years
  • Chronic renal failure defined by glomerular filtration rate (GFR)

    • group 1: GFR >90 mL/min with urinary biological abnormalities and GFR comprised between 90 and 60 mL/min
    • group 2: GFR comprised between 60 and 30 mL/min
    • group 3: GFR <30 mL/min but without dialysis therapy

Exclusion Criteria:

  • Chronic renal failure patient requiring dialysis therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608998

Contacts
Contact: Bernard CANAUD, Pr 00 33 4 67 33 84 95 b-canaud@chu-montpellier.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Montpellier, France, 34295
Contact: Bernard CANAUD, Pr    00 33 4 67 33 84 95    b-canaud@chu-montpellier.fr   
Principal Investigator: Bernard CANAUD, Pr         
Sub-Investigator: Jean-Paul CRISTOL, Pr         
Sub-Investigator: Hélène VERNHET, Pr         
Sub-Investigator: Kada KLOUCHE, Dr         
Sub-Investigator: Hélène LERAY-MORAGUES, Dr         
Sponsors and Collaborators
University Hospital, Montpellier
Ministry of Health, France
Investigators
Principal Investigator: Bernard CANAUD, Pr CHU Lapeyronie Montpellier France
Study Chair: Jean-Paul CRISTOL, Pr CHU Lapeyronie Montpellier France
Study Chair: Hélène VERNHET, Pr CHU Arnaud de Villeneuve Montpellier France
Study Chair: Kada KLOUCHE, Dr CHU Lapeyronie Montpellier France
Study Chair: Hélène LERAY-MORAGUES, Dr CHU Lapeyronie Montpellier France
  More Information

No publications provided

Responsible Party: Prof Bernard CANAUD, Centre Hospitalier Universitaire Montpellier France
ClinicalTrials.gov Identifier: NCT00608998     History of Changes
Other Study ID Numbers: UF 7853
Study First Received: January 23, 2008
Last Updated: March 28, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Montpellier:
Chronic renal failure
Vasculopathy
Cardiovascular risk
Chronic renal failure patients

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014