Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous

Chronic Kidney Disease stage3 Clinical Trial

Official title:

Role of Oral Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous in Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04311645
• Other study ID #: Charcoal CKD progression
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: farrag s mohamed
• Phone: 01143681697
• Email: faragsayed99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients with CKD stages iii and iv

Patients with age more than 18 years old

Exclusion Criteria:

Patients on regular hemodialysis

Patients with age less than 18 years old

Related Conditions & MeSH terms

• Chronic Kidney Disease stage3
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Activated charcoal
Activated charcoal

Dietary Supplement:
• Dry seeds
Dry seeds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Blacher 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. — View Citation

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. Review. — View Citation

Cook WL, Jassal SV. Prevalence of falls among seniors maintained on hemodialysis. Int Urol Nephrol. 2005;37(3):649-52. — View Citation

Friedman EA. Bowel as a kidney substitute in renal failure. Am J Kidney Dis. 1996 Dec;28(6):943-50. Review. — View Citation

Kurella 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. — View Citation

Mizobuchi 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. — View Citation

Niwa 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. — View Citation

Niwa 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. Review. — View Citation

Xie 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Secondary	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	baseline