NCT07208513

Brief Summary

Biomarkers of peritoneal fibrosis in patients with peritoneal dialysis were investigated by transcriptomics of exfoliated cells and metabolomics of exfoliated cells in peritoneal dialysis

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 28, 2025

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • (1) RNA-seq transcriptomics of exfoliated cells; (2) LC-MS metabolomics of permeable supernatant.

    Extract RNA from exfoliated cells in exupine, perform mRNA-seq analysis, collect exudate supernatant at the same time, perform metabolome analysis based on mass spectrometry detection, machine learning analysis of multi-omics data, and explore sensitive biomarkers for predicting peritoneal fibrosis based on the evaluation data of peritoneal samples of some patients.

    October 2024 - September 2026

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Peritoneal dialysis patients, hemodialysis control patients, and normal renal function control patients

You may qualify if:

  • Patients on peritoneal dialysis: a. Age 18-75 years; b. Regular abdominal dialysis due to uremia\> 3 months; c. Signed informed consent
  • Hemodialysis patients: a. Age 18-75 years; b. Due to regular hemodialysis due to uremia\> 3 months old, allogeneic kidney transplantation is planned; c. Signed informed consent
  • Patients with normal renal function: a. Age 18-75 years; b. Proposed elective inguinal hernia repair surgery; c. Signed informed consent.

You may not qualify if:

  • Patients on peritoneal dialysis: a. History of peritonitis in the past 3 months; b. History of abdominal tumors with peritoneal metastases
  • Hemodialysis patients: a. Previous abdominal dialysis history; b. History of abdominal tumors with peritoneal metastases Patients with normal renal function: a. History of chronic kidney disease; b. History of abdominal tumors with peritoneal metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA extracted from exfoliated cells in the exudate was collected for mRNA-seq analysis, and the exudate supernatant was collected at the same time, metabolome analysis was performed based on mass spectrometry detection, and machine learning analysis was performed on multi-omics data

MeSH Terms

Conditions

Peritoneal Fibrosis

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

chenhong feng, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start

October 20, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations