Kidney Transplant; ComplicationsCoGeriaTxNCT06104696
Comprehensive Geriatric Assessment in Kidney Transplantation
An observational study of Kidney Transplant; Complications and Frailty Syndrome, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Frailty Syndrome, Depressive Syndrome
- What is being tested?
- Functional geriatric assessment
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Jan 2020to 2 Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant candidates and kidney transplant recipients aged 60+ years.
Who may be able to join
- kidney transplant candidates aged 60+ years
- kidney transplant recipients aged 60+ years
Who cannot join
- kidney transplant candidates aged below 60 years
- kidney transplant recipients aged below 60 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Nephrology Transplant Centre IKEM
Prague, 140 21
Silvie Rajnochova Bloudickova, MD, PhD, +420 26136 2223, sibl@ikem.cz
Hana Vankova, MD, PhD, +420 726 773 084, ha.van@seznam.cz
About this study
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.
Read the 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.
- Being tested
- Functional geriatric assessment
- Keywords
- kidney transplantation, geriatric, frailty, depression, pretransplant evaluation, comprehensive geriatric assessment, posttransplant
- Medical subject headings
- Frailty, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional geriatric assessmentProcedure or surgery
Examination of physical and mental status using standardized tests.
| Study group | Role | What they receive |
|---|---|---|
| Non-frail | Group of patients which will meet the criteria for non-frail according to the result of functional examination. Receives: Procedure: Functional geriatric assessment | |
| Pre-frail | Group of patients which will meet the criteria for pre-frail according to the result of functional examination. Receives: Procedure: Functional geriatric assessment | |
| Frail | Group of patients which will meet the criteria for frail according to the result of functional examination. Receives: Procedure: Functional geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2020-2040
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.
Measured: 2020-2040
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).
Measured: 2020-2040
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).
Measured: 2020-2040
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.
Measured: 2020-2040
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start2 Jan 2020
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Silvie Rajnochova Bloudickova, Institute for Clinical and Experimental Medicine
- Investigators
- Silvie Rajnochova Bloudickova, MD,PhD, Study director, Department of Nephrology, Institute for Clinical and Experimental MedicineHana Vankova, MD,PhD, Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104696
- Sponsor's protocol ID
- Geriatrics
- Acronym
- CoGeriaTx
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 30506632Cesari 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.
PubMed 26997416Stuck 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.
PubMed 8105269Haugen 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.
PubMed 30890577Turner 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.
PubMed 25336440
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06104696
- Acronym / sponsor ID
- CoGeriaTx / Geriatrics
- Keywords
- kidney transplantation, geriatric, frailty, depression, pretransplant evaluation, comprehensive geriatric assessment, posttransplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Jan 2040 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-frail | – | Procedure: Functional geriatric assessmentGroup of patients which will meet the criteria for non-frail according to the result of functional examination. |
| Pre-frail | – | Procedure: Functional geriatric assessmentGroup of patients which will meet the criteria for pre-frail according to the result of functional examination. |
| Frail | – | Procedure: Functional geriatric assessmentGroup of patients which will meet the criteria for frail according to the result of functional examination. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant candidates and kidney transplant recipients aged 60+ years.
Key inclusion criteria (2 listed)
- kidney transplant candidates aged 60+ years
- kidney transplant recipients aged 60+ years
Key exclusion criteria (2 listed)
- kidney transplant candidates aged below 60 years
- kidney transplant recipients aged below 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional geriatric assessmentExamination of physical and mental status using standardized tests. | Procedure or surgery | Frail, Non-frail, Pre-frail |
Primary outcome
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).
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.
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).
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Results publication: PubMed 30506632Kobashigawa 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.
- Results publication: PubMed 26997416Cesari 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.
- Results publication: PubMed 8105269Stuck 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.
- Results publication: PubMed 30890577Haugen 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.
- Results publication: PubMed 25336440Turner 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvie Rajnochova Bloudickova, MD,PhD study director
Department of Nephrology, Institute for Clinical and Experimental Medicine
Hana Vankova, MD,PhD principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications and Frailty Syndrome, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvie Rajnochova Bloudickova, MD,PhD (261362223 ext. +420, sibl@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty syndrome (Fried frailty phenotype) (time frame: 2020-2040). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06104696, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.