NCT04311645

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Status
unknown

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 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

March 14, 2020

Last Update Submit

May 12, 2020

Conditions

Chronic Kidney Disease stage3

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • comparison of dry seeds and activated charcoal in limitting progression of chronic kidney disease

    baseline

Study Arms (3)

1st group

OTHER

Oral activated charcoal in a dose of 30 gm/day

Drug: Activated charcoal

2nd group

OTHER

Dry seeds in a dose of 1 gm/ day

Dietary Supplement: Dry seeds

3rd group

NO INTERVENTION

control group

Interventions

Activated charcoalDRUG

Activated charcoal

1st group
Dry seedsDIETARY_SUPPLEMENT

Dry seeds

2nd group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CKD stages iii and iv
  • Patients with age more than 18 years old

You may not qualify if:

  • Patients on regular hemodialysis
  • Patients with age less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 18182793BACKGROUND

  • 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.

    PMID: 20797565BACKGROUND

  • 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. doi: 10.1093/ndt/6.2.105.

    PMID: 1906999BACKGROUND

  • 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.

    PMID: 29279852BACKGROUND

  • 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. doi: 10.1161/hy1001.096358.

    PMID: 11641313BACKGROUND

  • 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.

    PMID: 19478096BACKGROUND

  • Cook 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.

    PMID: 16307356BACKGROUND

  • 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. doi: 10.7326/0003-4819-146-3-200702060-00006.

    PMID: 17283348BACKGROUND

  • Friedman 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.

    PMID: 8957051BACKGROUND

MeSH Terms

Interventions

Charcoal

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic Chemicals

Central Study Contacts

farrag s mohamed

CONTACT

01143681697faragsayed99@gmail.com

Ashraf A Al-Shazly, Prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, internal medicine department, principal investigator

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 17, 2020

Study Start

August 1, 2020

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

May 14, 2020

Record last verified: 2020-05