Comprehensive Geriatric Assessment in Kidney Transplantation

NCT ID: NCT06104696

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-02

Study Completion Date

2040-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Kidney transplantation represents the best therapeutical option in patients in end stage kidney disease. At present, increasing number of older patients are referred for kidney transplantation. Patients' functional status has been shown to be associated with transplant outcomes.

The comprehensive geriatric assessment (CGA) of functional and mental status in older kidney transplant candidates might play an important and supportive role in the pre-transplant evaluation process, including acceptance for transplantation. In kidney transplant recipients, this examination might be useful to evaluate the impact of pre-transplant status on post-transplant course. Also in KTR, CGA may contribute to the improvement of functional status and quality of life independently from the graft function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant; Complications Frailty Syndrome Depressive Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-frail

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

Functional geriatric assessment

Intervention Type PROCEDURE

Examination of physical and mental status using standardized tests.

Pre-frail

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

Functional geriatric assessment

Intervention Type PROCEDURE

Examination of physical and mental status using standardized tests.

Frail

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

Functional geriatric assessment

Intervention Type PROCEDURE

Examination of physical and mental status using standardized tests.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional geriatric assessment

Examination of physical and mental status using standardized tests.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* kidney transplant candidates aged below 60 years
* kidney transplant recipients aged below 60 years
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Silvie Rajnochova Bloudickova

Head of Outpatient Clinic of Deparment of Nephrology, Transplant Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Silvie Rajnochova Bloudickova, MD,PhD

Role: STUDY_DIRECTOR

Department of Nephrology, Institute for Clinical and Experimental Medicine

Hana Vankova, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Third Faculty of Medicine Charles University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nephrology Transplant Centre IKEM

Prague, , Czechia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Silvie Rajnochova Bloudickova, MD,PhD

Role: CONTACT

261362223 ext. +420

Hana Vankova, MD,PhD

Role: CONTACT

261362223 ext. +420

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Silvie Rajnochova Bloudickova, MD, PhD

Role: primary

+420 26136 2223

Hana Vankova, MD, PhD

Role: backup

+420 726 773 084

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 30506632 (View on PubMed)

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.

Reference Type RESULT
PMID: 26997416 (View on PubMed)

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.

Reference Type RESULT
PMID: 8105269 (View on PubMed)

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.

Reference Type RESULT
PMID: 30890577 (View on PubMed)

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.

Reference Type RESULT
PMID: 25336440 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Geriatrics

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CAPABLE Transplant
NCT06326905 RECRUITING NA