NCT06531993

Brief Summary

Effect of pectin in chronic kidney disease patients

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
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_2

Status
not yet recruiting

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

June 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 10, 2024

Last Update Submit

July 27, 2024

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • effect of pectin in GFR improvement in ckd patients

    Measure eGFR using CKD epi equation,

    6 month

Study Arms (2)

Pectin group

ACTIVE COMPARATOR

Pectin treatment

Drug: Pectin

Placepo group

PLACEBO COMPARATOR

Standard of care

Drug: Pectin

Interventions

PectinDRUG

Using pectin as tablets 600 mg per day for 6 months

Pectin groupPlacepo group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of CKD patients (stage 3 and 4)
  • age between 18 and 60 years
  • Must be able to swallow tablets

You may not qualify if:

  • End stage renal disease ( stage 5 ) 2 - Patients with renal transplantation 3- pregnancy 4- Presence of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Pectins

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Ashraf Anwer Thabet

    Prof

    STUDY DIRECTOR

Central Study Contacts

Maha Gamal Mahmoud, Resident

CONTACT

01555004150gamalmaha749@gmail.com

Ashraf Anwer Thabt, Prof

CONTACT

ashrafshazly58@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pectin, a class of heteropolysaccharides based on polygalacturonic acid, is a safe and non-toxic natural food additive recommended by the Joint FAO/WHO Committee on Food Additives with no daily additive limit . Pectin is mainly obtained from apple pomace, citrus peels and sugar beets, ancurrently, commercial pectin contains ≥65% Gal-A (galacturonic acid)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 10, 2024

First Posted

August 1, 2024

Study Start

August 1, 2024

Primary Completion

March 1, 2025

Study Completion

August 1, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share