Activated Charcoal Use in Chronic Kidney Disease Patients

Phase 2

Not yet recruiting

• Conditions: End Stage Renal Disease (ESRD); CKD 5D, Hemodialysis; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
• Interventions: Drug: Phosphate Binders; Drug: Activated Charcoal

• Registration Number: NCT06906874
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Phosphate Binders	patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders.
Intervention group	Activated Charcoal	patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders in addition to oral activated charcoal capsules with meals
Intervention group	Phosphate Binders	patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders in addition to oral activated charcoal capsules with meals

Primary Outcome Measures

Name	Time	Method
Serum phosphorus levels	8 weeks	Difference between two groups of serum phosphorous level in mg/dL at the end of the study.

Secondary Outcome Measures

Name	Time	Method
The percentage of patients who achieved decreasing at least 3 points in The Worst Itching Intensity Numerical Rating Scale (WI NRS)	8 weeks	The (WI-NRS) is a validated 11-point scale, with scores ranging from 0 to 10 and with higher scores indicating greater itch intensity.