NCT00728806

Brief Summary

This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal dialysis (PD) patients with different types of peritoneal solute transport by differential proteomics techniques. This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

4.2 years

First QC Date

August 1, 2008

Last Update Submit

May 21, 2015

Conditions

Continuous Ambulatory Peritoneal Dialysis

Keywords

Continuous Ambulatory Peritoneal DialysisUltrafiltration failureBiomarkerProteomics

Eligibility Criteria

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

Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University

You may qualify if:

  • Continuous ambulatory peritoneal dialysis patients whose primary disease is chronic glomerulonephritis, The range of age is 20 to 65 year old.
  • serum albumin level ≥ 35 g/L.
  • Residual GFR ≥ 2 ml/min/1.73 m2.
  • ml/d ≤ urine output ≤ 1000 ml/d.
  • Subjects who agree to participate in the study and sign the informed consent.

You may not qualify if:

  • Patients who are secondary nephropathy.
  • Patients with congestive heart failure, angina, myocardial infarction, severe valvular heart disease, malignant hypertension, hypertensive encephalopathy or cerebrovascular accident.
  • Patients with chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peritoneal tissue will be collected at the time of peritoneal dialysis catheter insertion or extubation. Serum and dialysate samples will be collected for protein analysis.

Study Officials

  • Xueqing Yu, M.D. & Ph.D.

    1st Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CN(1)