---
title: Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
nct_id: NCT02259296
overall_status: UNKNOWN
phase: NA
sponsor: Shanghai Changzheng Hospital
study_type: INTERVENTIONAL
primary_condition: Renal Failure, Chronic
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02259296.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02259296"
ct_last_update_post_date: 2014-10-08
last_seen_at: "2026-05-12T06:14:06.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

**NCT ID:** [NCT02259296](https://clinicaltrials.gov/study/NCT02259296)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 2200
- **Lead Sponsor:** Shanghai Changzheng Hospital
- **Collaborators:** First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- **Conditions:** Renal Failure, Chronic
- **Start Date:** 2015-01
- **Completion Date:** 2017-12
- **CT.gov Last Update:** 2014-10-08

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **Lower eGFR for AVF creation** (EXPERIMENTAL)
- **Higher eGFR for AVF creation** (ACTIVE_COMPARATOR)

## Interventions

- **Lower eGFR for AVF construction** (PROCEDURE) — 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
- **Higher eGFR for AVF construction** (PROCEDURE) — 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

## Primary Outcomes

- **Maturation rate of AVF** _(time frame: 3 months)_ — 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
- **Primary and secondary patency rate of AVF** _(time frame: 2 years)_ — Assessed by duplex ultrasound

## Secondary Outcomes

- **Maturation time of AVF** _(time frame: 3 months)_
- **Complications of AVF** _(time frame: 2 years)_
- **AVF creation on ventricular volumes and left ventricular remodeling** _(time frame: 2 years)_
- **AVF creation on AVF creation on brain MRI and cognitive functions** _(time frame: 2 years)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02259296*  
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