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Recruiting NCT06104696

Comprehensive Geriatric Assessment in Kidney Transplantation

Observational Kidney Transplant; Complications Frailty Syndrome Depressive Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional geriatric assessment.
Who it may be relevant to
Registry conditions: Kidney Transplant; Complications, Frailty Syndrome, Depressive Syndrome. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Procedure Functional geriatric assessment
    Examination of physical and mental status using standardized tests.

Primary outcome measures

  • Frailty syndrome (Fried frailty phenotype) [Time frame: 2020-2040]
  • Acceptance for kidney transplantation (Number of patients listed for kidney transplantation and number of transplanted patients) [Time frame: 2020-2040]
  • Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events) [Time frame: 2020-2040]
  • Functional status evaluated by comprehensive geriatric assessment [Time frame: 2020-2040]
  • Depressive syndrome (amount of depressive symptoms measured by GDS scale) [Time frame: 2020-2040]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 1 center
  • Department of Nephrology Transplant Centre IKEM — Prague

Publications

  • 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 Socie PMID 30506632
  • 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 26997416
  • 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 8105269
  • 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 30890577
  • 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 25336440

Identifiers

NCT: NCT06104696 · Geriatrics

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗