Peritoneal DialysisNCT04888065
Understand the Association Between Peritoneal Dialysis Status and Gene Polymorphisms of VEGF and KDR
An observational study of Peritoneal Dialysis, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Dialysis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both gender, end stage renal disease on PD treatment
Who may be able to join
- 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.
Who cannot join
- Patients from hemodialysis to peritoneal dialysis;
- Patients who need peritoneal dialysis due to transplant-renal loss;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gene Polymorphisms of VEGF and KDR Are Associated With Initial High Transport Status in Peritoneal Dialysis
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.
- Conditions
- Peritoneal Dialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start10 May 2018
- Primary completion30 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUE QIAN, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888065
- Sponsor's protocol ID
- 2018-220
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36376833
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Polymorphisms of VEGF and KDR Are Associated With Initial High Transport Status in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT04888065
- Acronym / sponsor ID
- 2018-220
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both gender, end stage renal disease on PD treatment
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients from hemodialysis to peritoneal dialysis;
- Patients who need peritoneal dialysis due to transplant-renal loss;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between VEGF and KDR Gene polymorphisms and initial transport status in peritoneal dialysis
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 36376833Qian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUE QIAN, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between VEGF and KDR Gene polymorphisms and initial transport status in peritoneal dialysis (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.