Chronic Kidney Disease stage3Phase 2NCT04311645
Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous
A Phase 2 study testing Activated charcoal and Dry seeds in people with Chronic Kidney Disease stage3, run by Assiut University.
Trial summary
The study aims to explore the ability of Oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with CKD stages III and IV. To compare its effect with the effect of dry seeds as absorbents of uremic toxins Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease stage3
- What is being tested?
- Activated charcoal and Dry seeds
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to Aug 2021
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CKD stages iii and iv
- Patients with age more than 18 years old
Who cannot join
- Patients on regular hemodialysis
- Patients with age less than 18 years old
Trial locations and contacts
No sites are listed yet.
Ashraf A Al-Shazly, Prof contact
About this study
Official title: Role of Oral Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous in Chronic Kidney Disease
The study aims to explore the ability of Oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with CKD stages III and IV.
To compare its effect with the effect of dry seeds as absorbents of uremic toxins
Read the detailed description
In recent years, chronic kidney disease(CKD) has become a worldwide public health issue.
The main factors affecting the prognosis of patients with chronic kidney disease are its complications, including cardiovascular and cerebrovascular diseases, malnutrition, inflammation, atherosclerosis syndrome, and anemia.
The accumulation of uremic toxins, such as indoxyl sulfate and p-cresyl sulfate, is implicated in the progression of renal failure and cardiovascular disease.
For many patients, chronic kidney disease (CKD) is a progressive condition marked by deteriorating renal function ultimately leading to end-stage renal disease (ESRD) and many patients refuse to start chronic hemodialysis.
Therapeutic approaches that decrease the level of uremic toxins are a rational method for inhibiting this progression.
Many researches have been done aiming to find alternatives for chronic hemodialysis either for economic issues or psychological issues especially in elderly patients, as example:
- Gum Arabic in the remedy and amelioration of kidney dysfunction and end-stage renal disease
- skin as excretory root for urea, increasing sweat from sweat glands can support kidney function by excreting a good amount of what kidneys naturally excrete.
- The oral charcoal adsorbent reduces serum levels of indoxyl sulfate through adsorption of indole converted from dietary tryptophan in the gastrointestinal tract decreasing serum creatinine and urea level .
In this study, the clinical data supporting the role of oral activated charcoal in a dose of 30gm/ day for slowing the progression of CKD will be reviewed.
In this study, a trial will be done using dry seeds (lentils as an example) as an absorbent for uremic toxins comparing its effect with the effect of oral activated charcoal.
- Conditions
- Chronic Kidney Disease stage3
- Being tested
- Activated charcoal, Dry seeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated charcoalDrug
Activated charcoal
Dry seedsDietary supplement
Dry seeds
| Study group | Role | What they receive |
|---|---|---|
| 1st group | Other | Oral activated charcoal in a dose of 30 gm/day Receives: Drug: Activated charcoal |
| 2nd group | Other | Dry seeds in a dose of 1 gm/ day Receives: Dietary Supplement: Dry seeds |
| 3rd group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of blood urea, creatinine and phosphorous in patients with CKD before and after oral activated charcoal
to asses the mean of blood urea, creatinine and phosphorous in CKD patient before and after administration of activated charcoal
Measured: baseline
Secondary outcomes (1)
comparison of dry seeds and activated charcoal in limitting progression of chronic kidney disease
To compare dry seeds with activated charcoal as as alternative natural cheap methods that may help in limitting progression of CKD by measuring blood urea, creatinine, and phosphorous in all 3 groups of the study
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- More trials run by Assiut 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farrag Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311645
- Sponsor's protocol ID
- Charcoal CKD progression
- Status last verified
- May 2020
- First submitted
- 14 Mar 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunori G, Viola BF, Maiorca P, Cancarini G. How to manage elderly patients with chronic renal failure: conservative management versus dialysis. Blood Purif. 2008;26(1):36-40. doi: 10.1159/000110561. Epub 2008 Jan 10.
PubMed 18182793Niwa T. Indoxyl sulfate is a nephro-vascular toxin. J Ren Nutr. 2010 Sep;20(5 Suppl):S2-6. doi: 10.1053/j.jrn.2010.05.002.
PubMed 20797565Niwa T, Emoto Y, Maeda K, Uehara Y, Yamada N, Shibata M. Oral sorbent suppresses accumulation of albumin-bound indoxyl sulphate in serum of haemodialysis patients. Nephrol Dial Transplant. 1991;6(2):105-9. doi: 10.1093/ndt/6.2.105.
PubMed 1906999Xie L, Jin L, Feng J, Lv J. The Expression of AQP5 and UTs in the Sweat Glands of Uremic Patients. Biomed Res Int. 2017;2017:8629783. doi: 10.1155/2017/8629783. Epub 2017 Nov 27.
PubMed 29279852Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.
PubMed 11641313Mizobuchi M, Towler D, Slatopolsky E. Vascular calcification: the killer of patients with chronic kidney disease. J Am Soc Nephrol. 2009 Jul;20(7):1453-64. doi: 10.1681/ASN.2008070692. Epub 2009 May 28.
PubMed 19478096Cook WL, Jassal SV. Prevalence of falls among seniors maintained on hemodialysis. Int Urol Nephrol. 2005;37(3):649-52. doi: 10.1007/s11255-005-0396-9.
PubMed 16307356Kurella M, Covinsky KE, Collins AJ, Chertow GM. Octogenarians and nonagenarians starting dialysis in the United States. Ann Intern Med. 2007 Feb 6;146(3):177-83. doi: 10.7326/0003-4819-146-3-200702060-00006.
PubMed 17283348Friedman EA. Bowel as a kidney substitute in renal failure. Am J Kidney Dis. 1996 Dec;28(6):943-50. doi: 10.1016/s0272-6386(96)90399-6.
PubMed 8957051
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oral Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04311645
- Acronym / sponsor ID
- Charcoal CKD progression
- Conditions
- Chronic Kidney Disease stage3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 17 Mar 2020 (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.
The study aims to explore the ability of Oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with CKD stages III and IV.
To compare its effect with the effect of dry seeds as absorbents of uremic toxins
Detailed description
In recent years, chronic kidney disease(CKD) has become a worldwide public health issue.
The main factors affecting the prognosis of patients with chronic kidney disease are its complications, including cardiovascular and cerebrovascular diseases, malnutrition, inflammation, atherosclerosis syndrome, and anemia.
The accumulation of uremic toxins, such as indoxyl sulfate and p-cresyl sulfate, is implicated in the progression of renal failure and cardiovascular disease.
For many patients, chronic kidney disease (CKD) is a progressive condition marked by deteriorating renal function ultimately leading to end-stage renal disease (ESRD) and many patients refuse to start chronic hemodialysis.
Therapeutic approaches that decrease the level of uremic toxins are a rational method for inhibiting this progression.
Many researches have been done aiming to find alternatives for chronic hemodialysis either for economic issues or psychological issues especially in elderly patients, as example:
- Gum Arabic in the remedy and amelioration of kidney dysfunction and end-stage renal disease
- skin as excretory root for urea, increasing sweat from sweat glands can support kidney function by excreting a good amount of what kidneys naturally excrete.
- The oral charcoal adsorbent reduces serum levels of indoxyl sulfate through adsorption of indole converted from dietary tryptophan in the gastrointestinal tract decreasing serum creatinine and urea level .
In this study, the clinical data supporting the role of oral activated charcoal in a dose of 30gm/ day for slowing the progression of CKD will be reviewed.
In this study, a trial will be done using dry seeds (lentils as an example) as an absorbent for uremic toxins comparing its effect with the effect of oral activated charcoal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st group | Other | Drug: Activated charcoalOral activated charcoal in a dose of 30 gm/day |
| 2nd group | Other | Dietary Supplement: Dry seedsDry seeds in a dose of 1 gm/ day |
| 3rd group | No intervention | –control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with CKD stages iii and iv
- Patients with age more than 18 years old
Key exclusion criteria (2 listed)
- Patients on regular hemodialysis
- Patients with age less than 18 years old
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 charcoalActivated charcoal | Drug | 1st group |
| Dry seedsDry seeds | Dietary supplement | 2nd group |
Primary outcome
Mean of blood urea, creatinine and phosphorous in patients with CKD before and after oral activated charcoal
Time frame: baseline
to asses the mean of blood urea, creatinine and phosphorous in CKD patient before and after administration of activated charcoal
1 secondary outcome
comparison of dry seeds and activated charcoal in limitting progression of chronic kidney disease
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 18182793Brunori G, Viola BF, Maiorca P, Cancarini G. How to manage elderly patients with chronic renal failure: conservative management versus dialysis. Blood Purif. 2008;26(1):36-40. doi: 10.1159/000110561. Epub 2008 Jan 10.
- Background: PubMed 20797565Niwa T. Indoxyl sulfate is a nephro-vascular toxin. J Ren Nutr. 2010 Sep;20(5 Suppl):S2-6. doi: 10.1053/j.jrn.2010.05.002.
- Background: PubMed 1906999Niwa T, Emoto Y, Maeda K, Uehara Y, Yamada N, Shibata M. Oral sorbent suppresses accumulation of albumin-bound indoxyl sulphate in serum of haemodialysis patients. Nephrol Dial Transplant. 1991;6(2):105-9. doi: 10.1093/ndt/6.2.105.
- Background: PubMed 29279852Xie L, Jin L, Feng J, Lv J. The Expression of AQP5 and UTs in the Sweat Glands of Uremic Patients. Biomed Res Int. 2017;2017:8629783. doi: 10.1155/2017/8629783. Epub 2017 Nov 27.
- Background: PubMed 11641313Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.
- Background: PubMed 19478096Mizobuchi M, Towler D, Slatopolsky E. Vascular calcification: the killer of patients with chronic kidney disease. J Am Soc Nephrol. 2009 Jul;20(7):1453-64. doi: 10.1681/ASN.2008070692. Epub 2009 May 28.
- Background: PubMed 16307356Cook WL, Jassal SV. Prevalence of falls among seniors maintained on hemodialysis. Int Urol Nephrol. 2005;37(3):649-52. doi: 10.1007/s11255-005-0396-9.
- Background: PubMed 17283348Kurella M, Covinsky KE, Collins AJ, Chertow GM. Octogenarians and nonagenarians starting dialysis in the United States. Ann Intern Med. 2007 Feb 6;146(3):177-83. doi: 10.7326/0003-4819-146-3-200702060-00006.
- Background: PubMed 8957051Friedman EA. Bowel as a kidney substitute in renal failure. Am J Kidney Dis. 1996 Dec;28(6):943-50. doi: 10.1016/s0272-6386(96)90399-6.
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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.
Ashraf A Al-Shazly, Prof contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activated charcoal and Dry seeds in people with Chronic Kidney Disease stage3, run by Assiut University.
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 2 inclusion and 2 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 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact farrag s mohamed (01143681697, faragsayed99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of blood urea, creatinine and phosphorous in patients with CKD before and after oral activated charcoal (time frame: baseline). 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 NCT04311645, which also lists 9 linked publications.
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 May 2020.