Activated Charcoal Use in Chronic Kidney Disease Patients

Mansoura University

Status and phase: Not yet enrolling; Phase 2

Conditions: CKD 5D, Hemodialysis; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder; End Stage Renal Disease (ESRD)

Treatments: Drug: Activated Charcoal; Drug: Phosphate Binders

Study type: Interventional

Funder types: Other

Identifiers

NCT06906874

2024-117'2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult aged ≥18 years with ESRD.
2. Patients who had been on stable maintenance hemodialysis (3 times weekly) for at least 6 months.
3. Patients receiving phosphate binders according to standard protocols established by kidney disease: Improving Global Outcomes (KDIGO).

Exclusion criteria

1. Severely malnourished (as diagnosed by the department's dietitian).
2. Treated with overnight dialysis.
3. Primary hyperparathyroidism or persistent serum levels of intact parathyroid hormone greater than 800 pg/mL.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control group

Other group

Description:

patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders.

Treatment:

Drug: Phosphate Binders

Intervention group

Experimental group

Description:

patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders in addition to oral activated charcoal capsules with meals

Treatment:

Drug: Phosphate Binders

Drug: Activated Charcoal