Activated Charcoal Use in Chronic Kidney Disease Patients

NCT ID: NCT06906874

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control group

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

Group Type OTHER

Phosphate Binders

Intervention Type DRUG

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

Intervention group

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

Group Type EXPERIMENTAL

Activated Charcoal

Intervention Type DRUG

oral activated charcoal capsules

Phosphate Binders

Intervention Type DRUG

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

Interventions

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Activated Charcoal

oral activated charcoal capsules

Intervention Type DRUG

Phosphate Binders

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha Mansour

Principal investigator-Associate Professor of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urology and Nephrology Center

Al Mansurah, Please Select, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Basma M. Sayed Ahmed, M.Sc.

Role: CONTACT

+201207753307

Facility Contacts

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Urology and Nephrology Center Urology and Nephrology Center

Role: primary

+201207753307

Other Identifiers

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2024-117'2

Identifier Type: -

Identifier Source: org_study_id

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