NCT06104696

Brief Summary

This observational study aims to analyze the results of comprehensive geriatric assessment and to monitor the development of functional status in geriatric kidney transplant candidates and recipients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
167mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2020Jan 2040

Study Start

First participant enrolled

January 2, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2025

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2040

Expected
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

August 4, 2023

Last Update Submit

October 23, 2023

Conditions

Kidney Transplant; ComplicationsFrailty SyndromeDepressive Syndrome

Keywords

kidney transplantationgeriatricfrailtydepressionpretransplant evaluationcomprehensive geriatric assessmentposttransplant

Outcome Measures

Primary Outcomes (5)

  • Frailty syndrome (Fried frailty phenotype)

    Geriatric assessment of frailty syndrome in kidney transplant candidates and recipients. Evaluation of frailty syndrome based on Fried frailty phenotype, Short Physical Performance Battery (SPPB) and complex comprehensive geriatric assessment including cognitive frailty (Montreal Cognitive Assessment MoCA).

    2020-2040

  • Acceptance for kidney transplantation (Number of patients listed for kidney transplantation and number of transplanted patients)

    Acceptance for kidney transplantation based on both geriatric and nephrologic evaluation. Number of patients listed for kidney transplantation,number of transplanted patients and number of patients not accepted for transplantation.

    2020-2040

  • Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events)

    Outcomes of kidney transplantation based on both geriatric and nephrologic evaluation. Short- and long-term patient and graft survival, graft function, post-transplant related adverse events (infection rate, MACE, death, days of hospitalisation).

    2020-2040

  • Functional status evaluated by comprehensive geriatric assessment

    Functional status evaluated by comprehensive geriatric assessment in geriatric kidney transplant candidates and recipients including evaluation of mobility (Short Physical Performance Battery, SPPB, walking speed m/s, muscle strenght measured by hand-grip) and cognition (Montreal Cognitive Assessment, MoCA), self-sufficiency and/or dysability (Activities of Daily Living, ADL, Instrumental Activities of Daily Living, IADL).

    2020-2040

  • Depressive syndrome (amount of depressive symptoms measured by GDS scale)

    Depressive syndrome in geriatric kidney transplant candidates and recipients. amount of depressive symptoms measured by GDS (Geriatric Depression Scale) scale by Yesavage.

    2020-2040

Study Arms (3)

Non-frail

Group of patients which will meet the criteria for non-frail according to the result of functional examination.

Procedure: Functional geriatric assessment

Pre-frail

Group of patients which will meet the criteria for pre-frail according to the result of functional examination.

Procedure: Functional geriatric assessment

Frail

Group of patients which will meet the criteria for frail according to the result of functional examination.

Procedure: Functional geriatric assessment

Interventions

Functional geriatric assessmentPROCEDURE

Examination of physical and mental status using standardized tests.

FrailNon-frailPre-frail

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kidney transplant candidates and kidney transplant recipients aged 60+ years.

You may qualify if:

  • kidney transplant candidates aged 60+ years
  • kidney transplant recipients aged 60+ years

You may not qualify if:

  • kidney transplant candidates aged below 60 years
  • kidney transplant recipients aged below 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology Transplant Centre IKEM

Prague, 140 21, Czechia

RECRUITING

Related Publications (5)

  • Kobashigawa J, Dadhania D, Bhorade S, Adey D, Berger J, Bhat G, Budev M, Duarte-Rojo A, Dunn M, Hall S, Harhay MN, Johansen KL, Joseph S, Kennedy CC, Kransdorf E, Lentine KL, Lynch RJ, McAdams-DeMarco M, Nagai S, Olymbios M, Patel J, Pinney S, Schaenman J, Segev DL, Shah P, Singer LG, Singer JP, Sonnenday C, Tandon P, Tapper E, Tullius SG, Wilson M, Zamora M, Lai JC. Report from the American Society of Transplantation on frailty in solid organ transplantation. Am J Transplant. 2019 Apr;19(4):984-994. doi: 10.1111/ajt.15198. Epub 2018 Dec 22.

    PMID: 30506632RESULT

  • Cesari M, Marzetti E, Thiem U, Perez-Zepeda MU, Abellan Van Kan G, Landi F, Petrovic M, Cherubini A, Bernabei R. The geriatric management of frailty as paradigm of "The end of the disease era". Eur J Intern Med. 2016 Jun;31:11-4. doi: 10.1016/j.ejim.2016.03.005. Epub 2016 Mar 18.

    PMID: 26997416RESULT

  • Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6. doi: 10.1016/0140-6736(93)92884-v.

    PMID: 8105269RESULT

  • Haugen CE, Chu NM, Ying H, Warsame F, Holscher CM, Desai NM, Jones MR, Norman SP, Brennan DC, Garonzik-Wang J, Walston JD, Bingaman AW, Segev DL, McAdams-DeMarco M. Frailty and Access to Kidney Transplantation. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):576-582. doi: 10.2215/CJN.12921118. Epub 2019 Mar 19.

    PMID: 30890577RESULT

  • Turner G, Clegg A; British Geriatrics Society; Age UK; Royal College of General Practioners. Best practice guidelines for the management of frailty: a British Geriatrics Society, Age UK and Royal College of General Practitioners report. Age Ageing. 2014 Nov;43(6):744-7. doi: 10.1093/ageing/afu138.

    PMID: 25336440RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine samples

MeSH Terms

Conditions

FrailtyDepressive DisorderDepression

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Silvie Rajnochova Bloudickova, MD,PhD

    Department of Nephrology, Institute for Clinical and Experimental Medicine

    STUDY DIRECTOR

  • Hana Vankova, MD,PhD

    Charles University, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvie Rajnochova Bloudickova, MD,PhD

CONTACT

261362223sibl@ikem.cz

Hana Vankova, MD,PhD

CONTACT

261362223ha.van@seznam.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Outpatient Clinic of Deparment of Nephrology, Transplant Center

Study Record Dates

First Submitted

August 4, 2023

First Posted

October 27, 2023

Study Start

January 2, 2020

Primary Completion

January 2, 2025

Study Completion (Estimated)

January 2, 2040

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

CZ(1)