Multi-omics Analysis of Chronic Kidney Disease

• Sponsor: Shanghai 10th People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05543291
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD	Behavioral: renal function

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Multi-omics Analysis of Chronic Kidney Disease
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism [baseline]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrolgoy, Shanghai 10th People's Hospital	Shanghai	Shanghai	China	200072

Sponsors and Collaborators

• Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ai Peng, Shanghai tenth People's Hospital, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT05543291
• Other Study ID Numbers: SHYS-IEC-5.0/22K162/P01
• First Posted: Sep 16, 2022
• Last Update Posted: Sep 16, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 16, 2022