Frailty Assessment Among Kidney Transplant Candidates | NCT04811417

Studies
Frailty Assessment Among Kidney Transplant Candidates

NCT04811417

Sponsor

Parc de Salut Mar

Status

Completed

Last Update Posted

Sep 22, 2021Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Frailty
Kidney Transplant; Complications

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2015Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 19, 2021

First Posted Date

Mar 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2021

Last Update Posted Date

Sep 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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..

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of frailty among KT candidates	Prevalence of frailty according FRIED and FRAIL scale	2015-2020
Biomarkers of frailty among KT candidates	Serum samples for biomarkers	2015-2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

KT candidates accepted for the KT waiting list

Exclusion Criteria:

No willing for participating
Difficulty in understanding Spanish or English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

KT candidates (>18 years-old) accepted for the KT waiting list and willing to participate

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided