NCT03794401

Brief Summary

This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

4.2 years

First QC Date

January 1, 2019

Last Update Submit

February 28, 2022

Conditions

Chronic Kidney Disease

Keywords

body compositionchronic kidney diseasedietary patterngut microbiot

Outcome Measures

Primary Outcomes (2)

  • renal outcome

    a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation

    3-year follow-up

  • cardiovascular outcome

    a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke

    3-year follow-up

Secondary Outcomes (2)

  • all-cause mortality

    3-year follow-up

  • neurological outcome

    3-year follow-up

Other Outcomes (1)

  • change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years

    2-year

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Regional Hospital

You may qualify if:

  • Patients with CKD stage 3-5 defined as eGFR \<60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.

You may not qualify if:

  • Patients with active cancer
  • Patients with liver cirrhosis
  • Patients with a cardiac pacemaker or metallic implants,
  • Patients are amputees
  • Pregnant women
  • Patients with inherited renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine, feces

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • SZU-CHUNG HUNG

    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TING-YUN LIN

CONTACT

+886-2-66289779water_h2o_6@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 7, 2019

Study Start

April 1, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

TW(1)