Chronic Kidney DiseaseADIFENCT03385902
Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
A study testing optimal start time and late start time in people with Chronic Kidney Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- optimal start time and late start time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2018to 20 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
- Expected to commence maintenance hemodialysis as their renal replacement treatment
- Agreeable to randomization
Who cannot join
- Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
- With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
- Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
- Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body )
- Hepatocirrhosis
- Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)
Show all 12Show fewer
- Acute infection within 1 month
- Bad habit which is difficult to withdrawal such as alcohol abuse
- Poor compliance and could not be treated according to the protocol
- Being pregnant, nursing or having a plan for pregnancy
- Life expectancy less than 1 year
- The investigator confirm that should not enroll in the study with any other cases
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
About this study
Official title: Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics
The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.
Read the detailed description
The optimal time of dialysis initiation is still controversial. Estimated glomerular filtration rate (eGFR) which is now widely used as the assessment of timing of dialysis is lack of specificity. Some clinical factors such as heart failure, volume overload, malnutrition also determine the dialysis time. But these subjective judgements do not have a standard. So there is no quantitative assessment of timing of dialysis initiation. The research team developed a novel equation named DIFE (Dialysis Initiation based on Fuzzy mathematics Equation) with data from a retrospective multicenter cohort by fuzzy mathematical methods to combine these clinical factors and lab indexes. The DIFE was confirmed to be more accurate and convenient to use in clinical practice than eGFR only at the assessment of dialysis initiation time in the internal validation. For further validation of the DIFE, the team will conduct a multicenter randomized controlled trial. Patients who need hemodialysis will be randomized to optimal start dailysis group or late start dailysis group by the assessment of the DIFE. Based on the comparison of the two groups, this trial will provide evidence for the optimal timing of dialysis initiation in patients with end-stage renal disease by the DIFE.
- Conditions
- Chronic Kidney Disease
- Being tested
- optimal start time, late start time
- Keywords
- end-stage renal disease, timing of dialysis initiation, hemodialysis, fuzzy mathematics, glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimal start timeOther
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
late start timeOther
patients will start hemodialysis when their DIFE less than 30
| Study group | Role | What they receive |
|---|---|---|
| optimal start dialysis group | Experimental | The DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time. Receives: Other: optimal start time |
| late start dialysis group | Active comparator | the DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time. Receives: Other: late start time |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
proportion of patients who die from any cause
Measured: from the date of enrollment until the end of study, assessed up to 3 years
cerebro-cardiovascular mortality
proportion of patients who die from cerebro-cardiovascular disease
Measured: 3 years, from the date of enrollment until the end of study
Secondary outcomes (7)
cerebro-cardiovascular events
proportion of patients who suffer from cardiovascular events, which include nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack,new-onset angina, acute heart failure or severe arrhythmia.
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
hospitalization
proportion of patients admitted to hospital
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Nutrition assessment
assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
the change of quality of life
use short form-36 reported by the patients to assess the patient's quality of life
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Medical cost
the cost by the patient, family and insurance during treatment
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Hemodialysis complications
the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
cognitive dysfunction
assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)
Measured: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start14 Apr 2018
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Fudan University, RenJi Hospital, Beijing Friendship Hospital, Huashan Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, General Hospital of Benxi Iron and Steel Co., Dalian Municipal Central Hospital, An Steel Group Hospital, The First Affiliated Hospital of the Fourth Military Medical University, General Hospital of Mining Industry Group Fuxin, Affiliated Zhongshan Hospital of Dalian University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Central Hospital Affiliated to Shenyang Medical Collage, First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Lin Hongli, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Hongli Lin, MD， PhD, Study director, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385902
- Sponsor's protocol ID
- YJ-KY-2017-119
- Acronym
- ADIFE
- Status last verified
- May 2026
- First submitted
- 21 Dec 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.
PubMed 20581422Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6.
PubMed 24508475Susantitaphong P, Altamimi S, Ashkar M, Balk EM, Stel VS, Wright S, Jaber BL. GFR at initiation of dialysis and mortality in CKD: a meta-analysis. Am J Kidney Dis. 2012 Jun;59(6):829-40. doi: 10.1053/j.ajkd.2012.01.015. Epub 2012 Apr 1.
PubMed 22465328Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.
PubMed 24492525Sood MM, Komenda P, Rigatto C, Hiebert B, Tangri N. The association of eGFR reporting with the timing of dialysis initiation. J Am Soc Nephrol. 2014 Sep;25(9):2097-104. doi: 10.1681/ASN.2013090953. Epub 2014 Mar 20.
PubMed 24652801Hwang SJ, Yang WC, Lin MY, Mau LW, Chen HC; Taiwan Society of Nephrology. Impact of the clinical conditions at dialysis initiation on mortality in incident haemodialysis patients: a national cohort study in Taiwan. Nephrol Dial Transplant. 2010 Aug;25(8):2616-24. doi: 10.1093/ndt/gfq308. Epub 2010 Jun 2.
PubMed 20519231Chen J, Liu Y, Chen X, Sun X, Li W, Yang W, Li P, Sun X, Wang D, Jiang H, Shi W, Liu W, Fu P, Ding X, Chang M, Liu S, Yang X, Cao N, Chen M, Ni Z, Chen J, Sun S, Liang X, Wang H, He Y, Gao B, Wang J, Hao L, Liu J, Li S, He Q, Liu H, Yi N, Shao F, Jiao J, Ma Y, Yao L, Sun Y, Li D, Szczech L, Fang M, Odeh Z, Lin H. Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e023162. doi: 10.1136/bmjopen-2018-023162.
PubMed 31501092
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics
- ClinicalTrials.gov ID
- NCT03385902
- Acronym / sponsor ID
- ADIFE / YJ-KY-2017-119
- Conditions
- Chronic Kidney Disease
- Keywords
- end-stage renal disease, timing of dialysis initiation, hemodialysis, fuzzy mathematics, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Fudan University, RenJi Hospital, Beijing Friendship Hospital, Huashan Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, General Hospital of Benxi Iron and Steel Co., Dalian Municipal Central Hospital, An Steel Group Hospital, The First Affiliated Hospital of the Fourth Military Medical University, General Hospital of Mining Industry Group Fuxin, Affiliated Zhongshan Hospital of Dalian University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Central Hospital Affiliated to Shenyang Medical Collage, First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Guangdong Provincial People's Hospital
- Study start
- 14 Apr 2018 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 29 Dec 2017 (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.
The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.
Detailed description
The optimal time of dialysis initiation is still controversial. Estimated glomerular filtration rate (eGFR) which is now widely used as the assessment of timing of dialysis is lack of specificity. Some clinical factors such as heart failure, volume overload, malnutrition also determine the dialysis time. But these subjective judgements do not have a standard. So there is no quantitative assessment of timing of dialysis initiation. The research team developed a novel equation named DIFE (Dialysis Initiation based on Fuzzy mathematics Equation) with data from a retrospective multicenter cohort by fuzzy mathematical methods to combine these clinical factors and lab indexes. The DIFE was confirmed to be more accurate and convenient to use in clinical practice than eGFR only at the assessment of dialysis initiation time in the internal validation. For further validation of the DIFE, the team will conduct a multicenter randomized controlled trial. Patients who need hemodialysis will be randomized to optimal start dailysis group or late start dailysis group by the assessment of the DIFE. Based on the comparison of the two groups, this trial will provide evidence for the optimal timing of dialysis initiation in patients with end-stage renal disease by the DIFE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimal start dialysis group | Experimental | Other: optimal start timeThe DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time. |
| late start dialysis group | Active comparator | Other: late start timethe DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
- Expected to commence maintenance hemodialysis as their renal replacement treatment
- Agreeable to randomization
Key exclusion criteria (12 listed)
- Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
- With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
- Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
- Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body )
- Hepatocirrhosis
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 |
|---|---|---|
| optimal start timepatients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30. | Other | optimal start dialysis group |
| late start timepatients will start hemodialysis when their DIFE less than 30 | Other | late start dialysis group |
Primary outcome
all-cause mortality
Time frame: from the date of enrollment until the end of study, assessed up to 3 years
proportion of patients who die from any cause
cerebro-cardiovascular mortality
Time frame: 3 years, from the date of enrollment until the end of study
proportion of patients who die from cerebro-cardiovascular disease
7 secondary outcomes
cerebro-cardiovascular events
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
hospitalization
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Nutrition assessment
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
the change of quality of life
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Medical cost
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
Hemodialysis complications
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
cognitive dysfunction
Time frame: from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years
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 8 May 2026.
- Background: PubMed 20581422Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.
- Results publication: PubMed 24508475Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6.
- Results publication: PubMed 22465328Susantitaphong P, Altamimi S, Ashkar M, Balk EM, Stel VS, Wright S, Jaber BL. GFR at initiation of dialysis and mortality in CKD: a meta-analysis. Am J Kidney Dis. 2012 Jun;59(6):829-40. doi: 10.1053/j.ajkd.2012.01.015. Epub 2012 Apr 1.
- Results publication: PubMed 24492525Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.
- Results publication: PubMed 24652801Sood MM, Komenda P, Rigatto C, Hiebert B, Tangri N. The association of eGFR reporting with the timing of dialysis initiation. J Am Soc Nephrol. 2014 Sep;25(9):2097-104. doi: 10.1681/ASN.2013090953. Epub 2014 Mar 20.
- Results publication: PubMed 20519231Hwang SJ, Yang WC, Lin MY, Mau LW, Chen HC; Taiwan Society of Nephrology. Impact of the clinical conditions at dialysis initiation on mortality in incident haemodialysis patients: a national cohort study in Taiwan. Nephrol Dial Transplant. 2010 Aug;25(8):2616-24. doi: 10.1093/ndt/gfq308. Epub 2010 Jun 2.
- Derived from this study: PubMed 31501092Chen J, Liu Y, Chen X, Sun X, Li W, Yang W, Li P, Sun X, Wang D, Jiang H, Shi W, Liu W, Fu P, Ding X, Chang M, Liu S, Yang X, Cao N, Chen M, Ni Z, Chen J, Sun S, Liang X, Wang H, He Y, Gao B, Wang J, Hao L, Liu J, Li S, He Q, Liu H, Yi N, Shao F, Jiao J, Ma Y, Yao L, Sun Y, Li D, Szczech L, Fang M, Odeh Z, Lin H. Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e023162. doi: 10.1136/bmjopen-2018-023162.
- 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.
Hongli Lin, MD， PhD study director
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optimal start time and late start time in people with Chronic Kidney Disease, run by The First Affiliated Hospital of Dalian Medical University 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 3 inclusion and 12 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 8 May 2026. 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?
all-cause mortality (time frame: from the date of enrollment until the end of study, assessed up to 3 years). 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?
On the ClinicalTrials.gov record for NCT03385902, which also lists 7 linked publications.
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 May 2026.