Comprehensive Geriatric Assessment in Kidney Transplantation (CoGeriaTx)

October 23, 2023 updated by: Silvie Rajnochova Bloudickova, Institute for Clinical and Experimental Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Silvie Rajnochova Bloudickova, MD,PhD
  • Phone Number: +420 261362223
  • Email: sibl@ikem.cz

Study Contact Backup

  • Name: Hana Vankova, MD,PhD
  • Phone Number: +420 261362223
  • Email: ha.van@seznam.cz

Study Locations

  • Czechia
      • Praha, Czechia, 140 21
        • Recruiting
        • Department of Nephrology Transplant Centre IKEM
        • Sub-Investigator:
          • Silvie Rajnochová Bloudíčkova
        • Contact:
          • Silvie Rajnochova Bloudickova, MD, PhD
          • Phone Number: +420 26136 2223
          • Email: sibl@ikem.cz
        • Contact:
        • Principal Investigator:
          • Hana Vankova
        • Sub-Investigator:
          • Michal Schmalz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Kidney transplant candidates and kidney transplant recipients aged 60+ years.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2020-2040
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.
2020-2040
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).
2020-2040
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).
2020-2040
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.
2020-2040

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Estimated)

January 2, 2025

Study Completion (Estimated)

January 2, 2040

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Geriatrics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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