Comprehensive Geriatric Assessment in Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

— CoGeriaTx  

Official title:

Comprehensive Geriatric Assessment in Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104696
• Other study ID #: Geriatrics
• Status: Recruiting
• Start date: January 2, 2020
• Est. completion date: January 2, 2040

Study information

• Verified date: October 2023
• Source: Institute for Clinical and Experimental Medicine
• Contact: Silvie Rajnochova Bloudickova, MD,PhD
• Phone: 261362223
• Email: sibl[@]ikem.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2, 2040
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Syndrome
• Frailty
• Frailty Syndrome
• Kidney Transplant; Complications
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Czechia	Department of Nephrology Transplant Centre IKEM	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View 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- — View 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 — View 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. — View 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 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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