NCT04888065

Brief Summary

Peritoneal dialysis (PD) is an effective and successful way of renal replacement therapy. The initial transport status is related to distribution of blood vessels and micro inflammation state in peritoneum before PD. Vascular endothelial growth factor(VEGF) and its receptor, kinase insert domain containing receptor(KDR) may play important roles on initial transport status. This study include 200 PD patients from Renji Hospital in Shanghai, China. According to the 4h D/P Cr within three months of starting PD therapy, we analyzed the association between the polymorphisms of VEGF and KDR and initial peritoneal transport property.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration 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

May 10, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

April 27, 2021

Last Update Submit

May 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The relationship between VEGF and KDR Gene polymorphisms and initial transport status in peritoneal dialysis

    According to the 4h dialysate over plasma ratio for creatinine (D/P Cr) within three months of starting PD therapy, patients were divided into high transport(H) or high average transport(HA) (H/HA) group and low transport(L) or low average transport(LA) (L/LA) group. Gene polymorphisms of selected VEGF and KDR SNPs were analyzed using extracted blood DNA from these patients. We aimed to investigate the relationship between VEGF and KDR gene polymorphisms and initial peritoneal transport property.

    For each patient, the outcome would be cross sectional measured at the time the patient does first/initial Peritoneal Equilibration Test. The data collection time period of the study is within 3 months.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both gender, end stage renal disease on PD treatment

You may qualify if:

  • Patients are Han Chinese;
  • Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
  • Patients successfully complete the first peritoneal equilibration test(PET);
  • Follow up regularly in our PD center.

You may not qualify if:

  • Patients from hemodialysis to peritoneal dialysis;
  • Patients who need peritoneal dialysis due to transplant-renal loss;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 310115, China

Location

Related Publications (1)

  • Qian Y, Ding L, Cao L, Yu Z, Shao X, Wang L, Zhang M, Wang Q, Che X, Jiang N, Yan H, Fang W, Jin Y, Huang J, Gu A, Ni Z. Gene polymorphisms of VEGF and KDR are associated with initial fast peritoneal solute transfer rate in peritoneal dialysis. BMC Nephrol. 2022 Nov 14;23(1):365. doi: 10.1186/s12882-022-02975-5.

Study Officials

  • YUE QIAN, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 17, 2021

Study Start

May 10, 2018

Primary Completion

October 30, 2020

Study Completion

December 30, 2020

Last Updated

May 17, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations