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Recruiting NCT06906874

Activated Charcoal Use in Chronic Kidney Disease Patients

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Activated Charcoal, Phosphate Binders.
Who it may be relevant to
Registry conditions: End Stage Renal Disease (ESRD), CKD 5D, Hemodialysis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy and Safety of Activated Charcoal on Mineral Bone Disorder in Chronic Kidney Disease Patients

Overview

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.

Interventions

  • Drug Activated Charcoal
    oral activated charcoal capsules
  • Drug Phosphate Binders
    calcium-based or non-calcium based (sevelamer) binders

Primary outcome measures

  • Serum phosphorus levels [Time frame: 8 weeks]
Secondary outcome measures (1)
  • The percentage of patients who achieved decreasing at least 3 points in The Worst Itching Intensity Numerical Rating Scale (WI NRS) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Urology and Nephrology Center — Al Mansurah

Identifiers

NCT: NCT06906874 · 2024-117'2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗