FrailtyMar-KidNCT04811417
Frailty Assessment Among Kidney Transplant Candidates
An observational study of Frailty and Kidney Transplant; Complications, run by Parc de Salut Mar.
Trial summary
Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list. The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Kidney Transplant; Complications
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: KT candidates (>18 years-old) accepted for the KT waiting list and willing to participate
Who may be able to join
- KT candidates accepted for the KT waiting list
Who cannot join
- No willing for participating
- Difficulty in understanding Spanish or English
About this study
Official title: Frailty Assessment Among Kidney Transplant Candidates on the Waiting List
Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list.
The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty.
Read the detailed description
This is an observational study where KT candidates will be assessed for frailty according to:
- Frailty Fried Phenotype and
- FRAIL scale
Sociodemographics and clinical variables will be collected and serum samples will be obtained in order to implement further studies regarding biomarkers of frailty..
- Conditions
- Frailty, Kidney Transplant; Complications
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty among KT candidates
Prevalence of frailty according FRIED and FRAIL scale
Measured: 2015-2020
Biomarkers of frailty among KT candidates
Serum samples for biomarkers
Measured: 2015-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Jun 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M José Pérez Sáez, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811417
- Sponsor's protocol ID
- 2018/7798/I
- Acronym
- Mar-Kid
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment Among Kidney Transplant Candidates on the Waiting List
- ClinicalTrials.gov ID
- NCT04811417
- Acronym / sponsor ID
- Mar-Kid / 2018/7798/I
- Conditions
- Frailty, Kidney Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Mar 2021 (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.
Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list.
The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty.
Detailed description
This is an observational study where KT candidates will be assessed for frailty according to:
- Frailty Fried Phenotype and
- FRAIL scale
Sociodemographics and clinical variables will be collected and serum samples will be obtained in order to implement further studies regarding biomarkers of frailty..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- KT candidates (>18 years-old) accepted for the KT waiting list and willing to participate
Key inclusion criteria (1 listed)
- KT candidates accepted for the KT waiting list
Key exclusion criteria (2 listed)
- No willing for participating
- Difficulty in understanding Spanish or English
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
Prevalence of frailty among KT candidates
Time frame: 2015-2020
Prevalence of frailty according FRIED and FRAIL scale
Biomarkers of frailty among KT candidates
Time frame: 2015-2020
Serum samples for biomarkers
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 22 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Kidney Transplant; Complications, run by Parc de Salut Mar.
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 1 inclusion and 2 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 22 Sep 2021. 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?
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?
Prevalence of frailty among KT candidates (time frame: 2015-2020). 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 22 Sep 2021.