Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00374712
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00374712
Study Brief:
Protocol Section:
NCT00374712