CKD Stage 4NCT05705011
Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.
An observational study of CKD Stage 4 and CKD Stage 5, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ]. The main question[s] it aims to answer are: What determines the time to initiate dialysis? Cognitive impairment or frailty? What does predict the time to death? Presence of frailty… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- CKD Stage 4, CKD Stage 5, Frailty
- How many people
- 240 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2019to 12 Mar 2023
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older adults are diagnosed with advanced chronic kidney disease, namely, stage 4 and stage 5.
Who may be able to join
- Patients age 65 years or older.
- CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 separated by more than 3 months.
Who cannot join
- Patients younger than 65 years old.
- Chronic kidney disease stages 1,2, and 3.
- Dialysis dependence
- History of kidney transplantation.
- Initial visit with the health care provider.
- Recent acute kidney injury.
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- Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty)
- Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment
- Patients who are blind or with limb amputation.
- Patients who refuse to participate.
Trial locations and contacts
1 site in 1 country.
Romania1 site
University of Medicine and Pharmacy "Grigore T. Popa"
Iași, 700115
About this study
Official title: Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.
This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ].
The main question[s] it aims to answer are:
- What determines the time to initiate dialysis? Cognitive impairment or frailty?
- What does predict the time to death? Presence of frailty or cognitive impairment?
- What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?
- Conditions
- CKD Stage 4, CKD Stage 5, Frailty, Cognitive Impairment
- Keywords
- CKD, FRAILTY, HRQOL
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death
The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5).
Measured: 36 months
Time to initiate dialysis.
The time from the assessment moment to start dialysis of an older adult with advanced CKD (
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2019
- Primary completion5 Mar 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage 4Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Hussien, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Hani Hussien, MD, Principal investigator, University of Medicine and Pharmacy "Grigore T. Popa" - Iași
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705011
- Sponsor's protocol ID
- Nephrogeriatrics
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05705011
- Acronym / sponsor ID
- Nephrogeriatrics
- Conditions
- CKD Stage 4, CKD Stage 5, Frailty, Cognitive Impairment
- Keywords
- CKD, FRAILTY, HRQOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 30 Jan 2023 (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.
This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ].
The main question[s] it aims to answer are:
- What determines the time to initiate dialysis? Cognitive impairment or frailty?
- What does predict the time to death? Presence of frailty or cognitive impairment?
- What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults are diagnosed with advanced chronic kidney disease, namely, stage 4 and stage 5.
Key inclusion criteria (2 listed)
- Patients age 65 years or older.
- CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 separated by more than 3 months.
Key exclusion criteria (10 listed)
- Patients younger than 65 years old.
- Chronic kidney disease stages 1,2, and 3.
- Dialysis dependence
- History of kidney transplantation.
- Initial visit with the health care provider.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to death
Time frame: 36 months
The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5).
Time to initiate dialysis.
Time frame: 36 months
The time from the assessment moment to start dialysis of an older adult with advanced CKD (
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 15 Feb 2024.
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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.
Hani Hussien, MD principal investigator
University of Medicine and Pharmacy "Grigore T. Popa" - Iași
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD Stage 4 and CKD Stage 5, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 2 inclusion and 10 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 15 Feb 2024. 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 Romania. 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?
Time to death (time frame: 36 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 15 Feb 2024.