Activated Charcoal Use in Chronic Kidney Disease Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Activated Charcoal

    Drug

    oral activated charcoal capsules

  • Phosphate Binders

    Drug

    calcium-based or non-calcium based (sevelamer) binders

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Intervention groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Serum phosphorus levels

Difference between two groups of serum phosphorous level in mg/dL at the end of the study.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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