Clinical trial NCT06104696: Comprehensive Geriatric Assessment in Kidney Transplantation
Official title: Comprehensive Geriatric Assessment in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant; Complications
Frailty Syndrome
Depressive Syndrome
Keywords: kidney transplantation
geriatric
frailty
depression
pretransplant evaluation
comprehensive geriatric assessment
posttransplant
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2023-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant candidates and kidney transplant recipients aged 60+ years.

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.

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.

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

Primary outcomes:
measure: Frailty syndrome (Fried frailty phenotype)
timeFrame: 2020-2040
measure: Acceptance for kidney transplantation (Number of patients listed for kidney transplantation and number of transplanted patients)
timeFrame: 2020-2040
measure: Outcomes of kidney transplantation (Graft and patient surival, number of patients with related adverse events)
timeFrame: 2020-2040
measure: Functional status evaluated by comprehensive geriatric assessment
timeFrame: 2020-2040
measure: Depressive syndrome (amount of depressive symptoms measured by GDS scale)
timeFrame: 2020-2040
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Department of Nephrology Transplant Centre IKEM
Study officials:
affiliation: Department of Nephrology, Institute for Clinical and Experimental Medicine
name: Silvie Rajnochova Bloudickova, MD,PhD
role: STUDY_DIRECTOR
affiliation: Third Faculty of Medicine Charles University
name: Hana Vankova, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.