Renal DialysisQualifragilysNCT03782519
Quality of Life of Frail Aged Patients in Incremental Hemodialysis
A study testing Dialysis frequency reduction and Frailty diagnosis in people with Renal Dialysis and Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Dialysis, Kidney Failure, Chronic, Frailty
- What is being tested?
- Dialysis frequency reduction and Frailty diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 783 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2019to Dec 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all patients (incident HD patients):
- Patient aged over 60 years
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
- Patient with Chronic Kidney Disease Stage 5 (GFR <15 ml/min/1.73m2)
- Urine output > 0,5 L per day
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- Kru ≥ 2 ml/min
- Outpatient with scheduled start of HD
- Understand and read french
- For randomized patients (frail incident HD patients):
- Frailty according to L. Fried criteria: score greater than or equal to 3/5
Who cannot join
- Inability to understand the reasons for the study; psychiatric disorders
- Active and/or treated neoplastic disease
- Scheduled kidney transplantation within 6 months
- Solid organ transplanted patient receiving immunosuppressive therapy
- Estimated life expectancy < 6 months
- Patient with diagnosis of severe chronic heart failure (> 2 congestive heart failure episodes requiring hospitalization in the year preceding the start of HD)
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- Legal disability or limited legal capacity
- Patient without health insurance
- Pregnant
- Patient in the period of exclusion of another study
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
Charline Vauchy, PhD, cvauchy@chu-besancon.fr
Cécile Courivaud, Prof.
About this study
Official title: Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study
End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions.
An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.
- Conditions
- Renal Dialysis, Kidney Failure, Chronic, Frailty
- Being tested
- Dialysis frequency reduction, Frailty diagnosis
- Keywords
- Incremental Hemodialysis, Nephrology
- Medical subject headings
- Kidney Failure, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis frequency reductionOther
At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)
Frailty diagnosisOther
Before randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question)
| Study group | Role | What they receive |
|---|---|---|
| Incremental hemodialysis | Experimental | Patients who will begin HD with two treatment sessions per week Receives: Other: Dialysis frequency reduction; Other: Frailty diagnosis |
| Conventional hemodialysis | Active comparator | Patients who will begin HD three times a week Receives: Other: Frailty diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)
Measured: One year after the initiation of HD
Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL)
Measured: One year after the initiation of HD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start9 May 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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 Renal DialysisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 783 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Courivaud, MD, PhD, Principal investigator, Nephrology, Dialysis and Renal Transplantation - CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782519
- Sponsor's protocol ID
- N/2016/75
- Acronym
- Qualifragilys
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.
PubMed 26027598
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study
- ClinicalTrials.gov ID
- NCT03782519
- Acronym / sponsor ID
- Qualifragilys / N/2016/75
- Conditions
- Renal Dialysis, Kidney Failure, Chronic, Frailty
- Keywords
- Incremental Hemodialysis, Nephrology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 783 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Dec 2018 (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.
End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions.
An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incremental hemodialysis | Experimental | Other: Dialysis frequency reduction, Other: Frailty diagnosisPatients who will begin HD with two treatment sessions per week |
| Conventional hemodialysis | Active comparator | Other: Frailty diagnosisPatients who will begin HD three times a week |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged over 60 years
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
- Patient with Chronic Kidney Disease Stage 5 (GFR <15 ml/min/1.73m2)
- Urine output > 0,5 L per day
Key exclusion criteria (11 listed)
- Inability to understand the reasons for the study; psychiatric disorders
- Active and/or treated neoplastic disease
- Scheduled kidney transplantation within 6 months
- Solid organ transplanted patient receiving immunosuppressive therapy
- Estimated life expectancy < 6 months
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 |
|---|---|---|
| Dialysis frequency reductionAt initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD) | Other | Incremental hemodialysis |
| Frailty diagnosisBefore randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question) | Other | Conventional hemodialysis, Incremental hemodialysis |
Primary outcome
Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)
Time frame: One year after the initiation of HD
Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL)
Time frame: One year after the initiation of HD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 26027598Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.
- 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.
Cécile Courivaud, MD, PhD principal investigator
Nephrology, Dialysis and Renal Transplantation - CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysis frequency reduction and Frailty diagnosis in people with Renal Dialysis and Kidney Failure, Chronic, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 11 inclusion and 11 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 5 Apr 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD (+33381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36) (time frame: One year after the initiation of HD). 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 NCT03782519, 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 5 Apr 2022.