Renal Failure, ChronicTACTICNCT02259296
Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
A study testing Lower eGFR for AVF construction and Higher eGFR for AVF construction in people with Renal Failure, Chronic, run by Shanghai Changzheng Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Failure, Chronic
- What is being tested?
- Lower eGFR for AVF construction and Higher eGFR for AVF construction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Renal Failure, Chronic
- Being tested
- Lower eGFR for AVF construction, Higher eGFR for AVF construction
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower eGFR for AVF constructionProcedure or surgery
Also called late AVF construction
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 constructionProcedure or surgery
Also called early AVF construction
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
| Study group | Role | What they receive |
|---|---|---|
| Lower eGFR for AVF creation | Experimental | Not described Receives: Procedure: Lower eGFR for AVF construction |
| Higher eGFR for AVF creation | Active comparator | Not described Receives: Procedure: Higher eGFR for AVF construction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Primary and secondary patency rate of AVF
Assessed by duplex ultrasound
Measured: 2 years
Secondary outcomes (4)
Maturation time of AVF
Assessed by duplex ultrasound
Measured: 3 months
Complications of AVF
Assessed by duplex ultrasound
Measured: 2 years
AVF creation on ventricular volumes and left ventricular remodeling
Assessed by doppler echocardiography
Measured: 2 years
AVF creation on AVF creation on brain MRI and cognitive functions
Cognitive functions are assessed by psychic and autonomy scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Changlin Mei, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, Principal investigator, Division of Nephrology, Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259296
- Sponsor's protocol ID
- CZHKI-HDVA-001
- Acronym
- TACTIC
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT02259296
- Acronym / sponsor ID
- TACTIC / CZHKI-HDVA-001
- Conditions
- Renal Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- 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
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;
- Contraindications to AVF construction:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower eGFR for AVF constructionAlso: late AVF constructionLower 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 | Procedure or surgery | Lower eGFR for AVF creation |
| Higher eGFR for AVF constructionAlso: early AVF constructionHigher 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 | Procedure or surgery | Higher eGFR for AVF creation |
Primary outcome
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
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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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.
Changlin Mei principal investigator
Division of Nephrology, Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lower eGFR for AVF construction and Higher eGFR for AVF construction in people with Renal Failure, Chronic, run by Shanghai Changzheng Hospital.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Gao (+862181885397, gaoxiang43100636@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation rate of AVF (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2014.