Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia (NCT00374712) | Clinical Trial Compass
TerminatedNot Applicable
Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia
Stopped: terminated
France40 participantsStarted 2005-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
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 Criteria:
* 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)