CoGeriaTx: Comprehensive Geriatric Assessment in Kidney Transplantation

Sponsor
Institute for Clinical and Experimental Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT06104696
Collaborator
(none)
1,000
1
240
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Functional geriatric assessment

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comprehensive Geriatric Assessment in Kidney Transplantation
Actual Study Start Date :
Jan 2, 2020
Anticipated Primary Completion Date :
Jan 2, 2025
Anticipated Study Completion Date :
Jan 2, 2040

Arms and Interventions

Arm Intervention/Treatment
Non-frail

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

Procedure: Functional geriatric assessment
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.

Procedure: Functional geriatric assessment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Frailty syndrome (Fried frailty phenotype) [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) [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) [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 [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) [2020-2040]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nephrology Transplant Centre IKEM Praha Czechia 140 21

Sponsors and Collaborators

  • Institute for Clinical and Experimental Medicine

Investigators

  • Study Director: Silvie Rajnochova Bloudickova, MD,PhD, Department of Nephrology, Institute for Clinical and Experimental Medicine
  • Principal Investigator: Hana Vankova, MD,PhD, Third Faculty of Medicine Charles University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvie Rajnochova Bloudickova, Head of Outpatient Clinic of Deparment of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT06104696
Other Study ID Numbers:
  • Geriatrics
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Silvie Rajnochova Bloudickova, Head of Outpatient Clinic of Deparment of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023