Uremic ToxinPhase 2/3NCT05540431
Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
A Phase 2/3 study testing Activated Charcoal and Probiotic in people with Uremic Toxin, run by Waleed Khaild Rahman Kareem Al-kabi at 1 site in Iraq.
Trial summary
Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level. Condition or disease: chronic kidney disease Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Uremic Toxin
- What is being tested?
- Activated Charcoal and Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 25 Sep 2022to 20 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with age more than 18 years old;
- Patients with CKD;
- Both genders will be included.
Who cannot join
- Patient with age less than 18 years old;
- Inability or rejection to take activated charcoal or probiotic;
- Clinically unstable;
- Pregnant;
- Unlikely to adhere to study procedure (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism).
Trial locations and contacts
1 site in 1 country.
About this study
Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level.
Condition or disease:
chronic kidney disease
Read the detailed description
Chronic kidney disease (CKD) is characterized by a gradual decrease in the glomerular filtration rate (GFR) and proteinuria. CKD is a global health problem, and its incidence has been increasing. The estimated global prevalence of CKD is 8-14%. When kidney function deteriorates gradually, many metabolites accumulate in the body. These accumulated substances, termed as uremic toxins (UTs), can result in adverse pathophysiological outcomes. UTs can affect multiple organs and cause renal fibrosis, vascular calcification, anemia, peripheral arterial disease, adynamic bone disease, adipocyte dysfunction with insulin resistance, impaired immune system, and uremic pruritus.
The pathophysiological mechanisms through which UTs cause multiple organ damage are complex and not completely understood. These mechanisms may include inflammation, reactive oxidative stress, cellular transdifferentiation, impaired mitochondria function, intestinal barrier destruction, and changes in intestinal microbiota.
- Conditions
- Uremic Toxin
- Being tested
- Activated Charcoal, Probiotic, No intervention
- Keywords
- Indoxyl sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated CharcoalDrug
RCT
ProbioticDietary supplement
RCT
No interventionOther
RCT
| Study group | Role | What they receive |
|---|---|---|
| Activated charcoal | Other | 1st group
Oral activated charcoal
20 to 25 patient with CKD will receive standard care plus Activated charcoal capsule (charconut) three times dialy for six weeks. Receives: Drug: Activated Charcoal |
| Probiotic | Other | 2nd group
Oral probiotic
20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks. Receives: Dietary Supplement: Probiotic |
| Control group | Other | 3rd group
Control group
20 to 25 patient with CKD will receive standard care only for six weeks. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving of blood urea
The concentration of blood urea(mmol/L),dL) ) in all blood samples
Measured: Baseline to 6 week
Indoxyl sulfate assay
The concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples
Measured: Baseline to 6 week
Improving of serum creatinine mg/dL
The concentration of serum creatinine(mg/dL) in all blood sample
Measured: Baseline to 6 week
Secondary outcomes (1)
Nutrition status
The concentration of albumin(g/dL) in the subjects' blood samples
Measured: Baseline to 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uremic ToxinStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (clinical trial)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waleed Khaild Rahman Kareem Al-kabi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Waleed Khaild Rahman Kareem Al-kabi, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540431
- Sponsor's protocol ID
- Uremic toxin in CKD
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saran R, Robinson B, Abbott KC, Agodoa LYC, Bhave N, Bragg-Gresham J, Balkrishnan R, Dietrich X, Eckard A, Eggers PW, Gaipov A, Gillen D, Gipson D, Hailpern SM, Hall YN, Han Y, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kovesdy CP, Lavallee D, Leslie J, McCullough K, Modi Z, Molnar MZ, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Rao P, Repeck K, Rhee CM, Schrager J, Schaubel DE, Selewski DT, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Tamura MK, Tilea A, Tong L, Wang D, Wang M, Woodside KJ, Xin X, Yin M, You AS, Zhou H, Shahinian V. US Renal Data System 2017 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2018 Mar;71(3 Suppl 1):A7. doi: 10.1053/j.ajkd.2018.01.002. No abstract available.
PubMed 29477157
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05540431
- Acronym / sponsor ID
- Uremic toxin in CKD
- Conditions
- Uremic Toxin
- Keywords
- Indoxyl sulfate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Waleed Khaild Rahman Kareem Al-kabiUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 14 Sep 2022 (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.
Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level.
Condition or disease:
chronic kidney disease
Detailed description
Chronic kidney disease (CKD) is characterized by a gradual decrease in the glomerular filtration rate (GFR) and proteinuria. CKD is a global health problem, and its incidence has been increasing. The estimated global prevalence of CKD is 8-14%. When kidney function deteriorates gradually, many metabolites accumulate in the body. These accumulated substances, termed as uremic toxins (UTs), can result in adverse pathophysiological outcomes. UTs can affect multiple organs and cause renal fibrosis, vascular calcification, anemia, peripheral arterial disease, adynamic bone disease, adipocyte dysfunction with insulin resistance, impaired immune system, and uremic pruritus.
The pathophysiological mechanisms through which UTs cause multiple organ damage are complex and not completely understood. These mechanisms may include inflammation, reactive oxidative stress, cellular transdifferentiation, impaired mitochondria function, intestinal barrier destruction, and changes in intestinal microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional (clinical trial)
| Arm | Type | Receives |
|---|---|---|
| Activated charcoal | Other | Drug: Activated Charcoal1st group Oral activated charcoal 20 to 25 patient with CKD will receive standard care plus Activated charcoal capsule (charconut) three times dialy for six weeks. |
| Probiotic | Other | Dietary Supplement: Probiotic2nd group Oral probiotic 20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks. |
| Control group | Other | Other: No intervention3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with age more than 18 years old;
- Patients with CKD;
- Both genders will be included.
Key exclusion criteria (5 listed)
- Patient with age less than 18 years old;
- Inability or rejection to take activated charcoal or probiotic;
- Clinically unstable;
- Pregnant;
- Unlikely to adhere to study procedure (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism).
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 CharcoalRCT | Drug | Activated charcoal |
| ProbioticRCT | Dietary supplement | Probiotic |
| No interventionRCT | Other | Control group |
Primary outcome
Improving of blood urea
Time frame: Baseline to 6 week
The concentration of blood urea(mmol/L),dL) ) in all blood samples
Indoxyl sulfate assay
Time frame: Baseline to 6 week
The concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples
Improving of serum creatinine mg/dL
Time frame: Baseline to 6 week
The concentration of serum creatinine(mg/dL) in all blood sample
1 secondary outcome
Nutrition status
Time frame: Baseline to 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 29477157Saran R, Robinson B, Abbott KC, Agodoa LYC, Bhave N, Bragg-Gresham J, Balkrishnan R, Dietrich X, Eckard A, Eggers PW, Gaipov A, Gillen D, Gipson D, Hailpern SM, Hall YN, Han Y, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kovesdy CP, Lavallee D, Leslie J, McCullough K, Modi Z, Molnar MZ, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Rao P, Repeck K, Rhee CM, Schrager J, Schaubel DE, Selewski DT, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Tamura MK, Tilea A, Tong L, Wang D, Wang M, Woodside KJ, Xin X, Yin M, You AS, Zhou H, Shahinian V. US Renal Data System 2017 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2018 Mar;71(3 Suppl 1):A7. doi: 10.1053/j.ajkd.2018.01.002. No abstract available.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Activated Charcoal and Probiotic in people with Uremic Toxin, run by Waleed Khaild Rahman Kareem Al-kabi at 1 site in Iraq.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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 Iraq. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed Khaild Rahman, Bachelor of pharmacy (+9647809763160, ph.waleedkhaild99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving of blood urea (time frame: Baseline to 6 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540431, which also lists 1 linked publication.
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 14 Sep 2022.