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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00374712
Other study ID # P031010
Secondary ID CRC 03161
Status Terminated
Phase N/A
First received September 12, 2005
Last updated November 6, 2007
Start date January 2005
Est. completion date November 2007

Study information

Verified date November 2007
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.


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 gender, and with comparable values for dialysis dose and daily protein intake. These two groups consist of one group of 20 adult, dialyzed patients with serum phosphate levels > 2.50 mM compared to another group of 20 adult, dialyzed ESRD patients with serum phosphate levels < 1.50 mM. The results of this study will allow to determine whether there is a relationship between extreme hyperphosphatemia and klotho gene polymorphisms in dialysed ESRD patients.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Time Perspective: Prospective


Locations

Country Name City State
France Clinique de l'Orangerie - Service de Néphrologie et Dialyse Aubervilliers

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Prié D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. Review. — View Citation

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