End Stage Renal Disease (ESRD)Phase 2NCT06906874
Activated Charcoal Use in Chronic Kidney Disease Patients
A Phase 2 study testing Activated Charcoal and Phosphate Binders in people with End Stage Renal Disease (ESRD) and CKD 5D, Hemodialysis, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), CKD 5D, Hemodialysis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- What is being tested?
- Activated Charcoal and Phosphate Binders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Please Select
Urology and Nephrology Center Urology and Nephrology Center, +201207753307, basmah.mohamed.1997@gmail.com
About this study
Official title: Efficacy and Safety of Activated Charcoal on Mineral Bone Disorder in Chronic Kidney Disease Patients
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.
- Conditions
- End Stage Renal Disease (ESRD), CKD 5D, Hemodialysis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- Being tested
- Activated Charcoal, Phosphate Binders
- Medical subject headings
- Kidney Failure, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated CharcoalDrug
oral activated charcoal capsules
Phosphate BindersDrug
calcium-based or non-calcium based (sevelamer) binders
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | patients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders. Receives: 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 Receives: Drug: Activated Charcoal; Drug: Phosphate Binders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus levels
Difference between two groups of serum phosphorous level in mg/dL at the end of the study.
Measured: 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)
The (WI-NRS) is a validated 11-point scale, with scores ranging from 0 to 10 and with higher scores indicating greater itch intensity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906874
- Sponsor's protocol ID
- 2024-117'2
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Activated Charcoal on Mineral Bone Disorder in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06906874
- Acronym / sponsor ID
- 2024-117'2
- Conditions
- End Stage Renal Disease (ESRD), CKD 5D, Hemodialysis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Phosphate Binderspatients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders. |
| Intervention group | Experimental | Drug: Activated Charcoal, Drug: Phosphate Binderspatients receiving standard care therapy of calcium-based or non-calcium based (sevelamer) binders in addition to oral activated charcoal capsules with meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Charcoaloral activated charcoal capsules | Drug | Intervention group |
| Phosphate Binderscalcium-based or non-calcium based (sevelamer) binders | Drug | Control group, Intervention group |
Primary outcome
Serum phosphorus levels
Time frame: 8 weeks
Difference between two groups of serum phosphorous level in mg/dL at the end of the study.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activated Charcoal and Phosphate Binders in people with End Stage Renal Disease (ESRD) and CKD 5D, Hemodialysis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basma M. Sayed Ahmed, M.Sc. (+201207753307, basma_mohamed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphorus levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.