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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.