Status:
TERMINATED
Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Chronic Kidney Disease
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
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 cardiovasc...
Detailed Description
The entire coding region of the klotho gene will be sequenced looking for functional variants and polymorphisms that differentiate two groups of adult dialyzed ESRD patients, matched for age and gende...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Malnutrition (body mass index \[BMI\] \< 15)
- Amputation of lower members (\> 10% of total body)
- Prolonged immobilization
- Secondary hyperparathyroidism (PTH \> 1400 pg/ml)
- Vitamin D deficiency (25OHD3 \< 10 ng/ml)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00374712
Start Date
January 1 2005
End Date
November 1 2007
Last Update
November 8 2007
Active Locations (1)
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1
Clinique de l'Orangerie - Service de Néphrologie et Dialyse
Aubervilliers, France, 93300