NCT02259296

Brief Summary

The timing for arteriovenous fistula (AVF) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. Lower estimated glomerular filtration rate (eGFR) patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months; primary and secondary patency rate of AVF, AVF construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF creation

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 23, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2.9 years

First QC Date

September 23, 2014

Last Update Submit

October 7, 2014

Conditions

Renal Failure, Chronic

Outcome Measures

Primary Outcomes (2)

  • Maturation rate of AVF

    Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm

    3 months

  • Primary and secondary patency rate of AVF

    Assessed by duplex ultrasound

    2 years

Secondary Outcomes (4)

  • Maturation time of AVF

    3 months

  • Complications of AVF

    2 years

  • AVF creation on ventricular volumes and left ventricular remodeling

    2 years

  • AVF creation on AVF creation on brain MRI and cognitive functions

    2 years

Study Arms (2)

Lower eGFR for AVF creation

EXPERIMENTAL
Procedure: Lower eGFR for AVF construction

Higher eGFR for AVF creation

ACTIVE COMPARATOR
Procedure: Higher eGFR for AVF construction

Interventions

Lower eGFR for AVF constructionPROCEDURE

Lower eGFR patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction

Also known as: late AVF construction
Lower eGFR for AVF creation
Higher eGFR for AVF constructionPROCEDURE

Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction

Also known as: early AVF construction
Higher eGFR for AVF creation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic renal failure, without AVF creation;
  • Estimated glomerular filtration rate (eGFR) \<15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<20ml/min 1.73m2 for diabetic kidney disease;
  • All study subjects must agree to participate in the study and provide written informed consent.

You may not qualify if:

  • Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;
  • Contraindications to AVF construction:
  • Allen's Test is positive, or arterial diameter\<2 mm; venous diameter\<2.5 mm or venous occlusion/stenosis.
  • Local infection.
  • Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ).
  • Mental illness that makes the patients unable to complete the trial.
  • Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Changlin Mei

    Division of Nephrology, Changzheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Gao

CONTACT

+862181885397gaoxiang43100636@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director, Division of Nephrology

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 8, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 8, 2014

Record last verified: 2014-10