Multi-omics Analysis of Chronic Kidney Disease

Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.

Study Overview

• Status: Recruiting
• Conditions: Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD
• Intervention / Treatment: Behavioral: renal function

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Haichao Wang; Phone Number: 15316167902; Email: whctidy@tongji.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Nephrolgoy, Shanghai 10th People's Hospital
      • Contact: Ai Peng, Ph.D., M.D.; Phone Number: 86-21-66302524; Email: pengai@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria:

1. Confirmed CKD patients.
2. Age≥18 years.

Exclusion criteria：

1. Age<18 years.
2. Patients with active gastrointestinal diseases, liver cirrhosis, cancer, active infection or cardiovascular event in the past 3 months, pregnancy or received renal replacement therapy.

Description

Inclusion Criteria:

Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled

Exclusion Criteria:

1. Age<18 years.
2. Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
3. Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy controls	Behavioral: renal function; levels of eGFR
mild CKD	Behavioral: renal function; levels of eGFR
Moderate CKD	Behavioral: renal function; levels of eGFR
ESRD	Behavioral: renal function; levels of eGFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism	Gut metagenome, fecal metabolome and serum metabolome were performed in this disease-severity classified CKD cohort, to identify the changes of microbial compositions and metabolism in CKD progression	baseline

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 11, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SHYS-IEC-5.0/22K162/P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No