NCT00374712

Brief Summary

Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
12 months until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 8, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 6, 2007

Conditions

Chronic Kidney DiseaseEnd Stage Renal DiseaseHyperphosphatemiaRenal Osteodystrophy

Keywords

PhosphateDialysisKlothoHemodialysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, end-stage renal disease patients treated by standard hemodialysis

You may qualify if:

  • Group 1
  • Stable hemodialysis patients for at least 3 months
  • Phosphatemia \> 2.5 mM
  • Kt/V \> 1.2
  • Total weekly phosphate removal \> 75 millimoles
  • Group 2
  • Stable hemodialysis patients for at least 3 months
  • Phosphatemia \< 1.5 mM
  • Kt/V \> 1.2
  • Total weekly phosphate removal \> 25 millimoles

You may not qualify if:

  • Age \> 80 years
  • Insufficient dialysis dose (Kt/V \< 1.2)
  • Total weekly phosphate removal \< 25 mM
  • Problems with vascular access for hemodialysis (central catheter, arteriovenous \[A-V\] fistula dysfunction)
  • Methods of dialysis different than the classical hemodialysis (peritoneal, hemofiltration, or hemodiafiltration with or without acetate)
  • Intolerance or allergy to ARYLANE M9 dialyzers
  • Hypocalcemia \< 2.0 mmol/liter
  • Hypophosphatemia \< 0.6 mmol/liter
  • Daily protein intake \< 0.6 g/kg/j
  • Parathyroidectomy at least 3 months prior to the study
  • Evolutive neoplasia with or without secondary lytic bone lesions
  • Intestinal malabsorption
  • Alcoholism
  • Corticotherapy
  • Treatment by bisphosphonates, fluor or recombinant PTH
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de l'Orangerie - Service de Néphrologie et Dialyse

Aubervilliers, 93300, France

Location

Related Publications (1)

  • Prie D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. doi: 10.1097/01.mnh.0000172716.41853.1e.

    PMID: 15930998RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicHyperphosphatemiaChronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Pablo URENA TORRES, MD

    Clinique de l'Orangerie, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 11, 2006

Study Start

January 1, 2005

Study Completion

November 1, 2007

Last Updated

November 8, 2007

Record last verified: 2007-11

Locations

FR(1)