About this trial
Hyperphosphatemia management is initially based on restricting dietary phosphorus intake. Hyperphosphatemia is almost always seen in patients on dialysis and may contribute to progressive vascular calcification. Considering that activated charcoal is generally well-tolerated and may have a favorable side effect profile compared to conventional phosphate binders, it presents a promising alternative. Until now, no clinical trial has primarily investigated the effect of activated charcoal on hyperphosphatemia in dialysis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult aged ≥18 years with ESRD.
Patients who had been on stable maintenance hemodialysis (3 times weekly) for at least 6 months.
Patients receiving phosphate binders according to standard protocols established by kidney disease: Improving Global Outcomes (KDIGO).
Disqualifiers
Severely malnourished (as diagnosed by the department's dietitian).
Treated with overnight dialysis.
Primary hyperparathyroidism or persistent serum levels of intact parathyroid hormone greater than 800 pg/mL.
Trial design
Parallel
Treatments tested in this trial
Activated Charcoal
Drugoral activated charcoal capsules
Phosphate Binders
Drugcalcium-based or non-calcium based (sevelamer) binders
Treatment groups
Trial outcomes
Primary outcomes
Serum phosphorus levels
Difference between two groups of serum phosphorous level in mg/dL at the end of the study.
Secondary outcomes
The percentage of patients who achieved decreasing at least 3 points in The Worst Itching Intensity Numerical Rating Scale (WI NRS)
The (WI-NRS) is a validated 11-point scale, with scores ranging from 0 to 10 and with higher scores indicating greater itch intensity.
Sponsors and contacts
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