NCT06906874

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 26, 2025

Last Update Submit

August 5, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Serum phosphorus levels

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

    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)

    8 weeks

Study Arms (2)

Control group

OTHER

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

Drug: Phosphate Binders

Intervention group

EXPERIMENTAL

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

Drug: Activated CharcoalDrug: Phosphate Binders

Interventions

Activated CharcoalDRUG

oral activated charcoal capsules

Intervention group
Phosphate BindersDRUG

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

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Please Select, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicChronic Kidney Disease-Mineral and Bone Disorder

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic Chemicals

Central Study Contacts

Basma M. Sayed Ahmed, M.Sc.

CONTACT

+201207753307basma_mohamed@mans.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator-Associate Professor of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

August 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

August 8, 2025

Record last verified: 2025-03

Locations

EG(1)