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NCT Number: NCT06104696

Comprehensive Geriatric Assessment in Kidney Transplantation

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.

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Key information

Conditions

Kidney Transplant; Complications Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Syndrome Frailty Frailty Syndrome Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology Transplant Centre IKEM

Prague, 140 21, Czechia

Location status: Recruiting

Location contact

Hana Vankova

PRINCIPAL_INVESTIGATOR

Hana Vankova, MD, PhD

CONTACT

[email protected]

+420 726 773 084

Michal Schmalz

SUB_INVESTIGATOR

Silvie Rajnochova Bloudickova

SUB_INVESTIGATOR

Silvie Rajnochova Bloudickova, MD, PhD

CONTACT

[email protected]

+420 26136 2223

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional geriatric assessment

Procedure

Examination of physical and mental status using standardized tests.

Primary outcomes

  1. Frailty syndrome (Fried frailty phenotype)

    Time frame: 2020-2040

    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).

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

    Time frame: 2020-2040

    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.

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

    Time frame: 2020-2040

    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).

  4. Functional status evaluated by comprehensive geriatric assessment

    Time frame: 2020-2040

    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).

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

    Time frame: 2020-2040

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Vankova, MD,PhD

CONTACT

[email protected]

261362223 ext. +420

Silvie Rajnochova Bloudickova, MD,PhD

CONTACT

[email protected]

261362223 ext. +420

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Acronym: CoGeriaTx

Important dates

Study start
2020
Primary completion
2025
Study completion
2040
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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