An interventional study of Blood sample and Geriatric assessment standardized in Chronic Kidney Failure, Frailty and Aging, sponsored by University Hospital, Bordeaux. Not yet recruiting at 3 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
Kidney transplantation (KT) benefit-risk ratio assessment is a challenge in a growing population of older patients with end-stage kidney disease. A pre-KT frailty phenotype has been found predictive of post-KT complications, but biological mechanisms of frailty are poorly known is these patients. Frailty is associated with chronic low-grade inflammation in the older general population, possibly through the inflammasome pathway. Our main objective is to assess if systemic activation of inflammasomes is associated with frailty in older candidates to KT.
Kidney transplantation (KT) benefit-risk ratio assessment is a challenge in a growing population of older patients with end-stage kidney disease. Chronic low-grade inflammation is a hallmark of biological aging and is associated with age-related diseases and frailty. Frailty is conceptually defined as an agerelated reduction in physiological reserve increasing vulnerability to stressors. A pre-KT frailty phenotype is associated with post-KT complications, including re-hospitalizations, delayed graft function, delirium and 5-year mortality. Taking pre-KT inflammation into account (serum level of CRP, IL6, sTNFR1) improves prediction of mortality on KT waiting-list, independently of comorbidity.
Molecular and cellular pathways of this inflammation are poorly known, and may involve inflammasomes. Inflammasomes are intra-cellular protein complexes whose assembly, upon stress signals, triggers maturation and release of pro-inflammatory cytokines named interleukine (IL)-1 and IL-18. Inflammasomes are involved in locomotor, cognitive and immune aging in mice, and systemic expression of inflammasomes genes is associated with mortality in older humans. Data is lacking about systemic activation of inflammasomes in older patients with end-stage kidney disease. Our main objective is to assess if pre-KT systemic activation of inflammasomes is associated with frailty in older candidates to KT.
We will measure systemic activation of inflammasomes in peripheral blood of older candidates to KT using cytokine bead-based multiplex assay, Single Molecule Array, intra-cytoplasmic staining, flow cytometry and RT-qPCR in peripheral blood mononuclear cells. Frailty will be measured using validated standardized criteria. A frailty phenotype is defined by at least 3 of the following criteria:
weight loss, exhaustion, muscle weakness, low physical activity, low gait speed.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
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Age ≥ 70
Inclusion in an industrial study refusing co-inclusion in our study
Frailty will be measured clinically using reference criteria in the general population and validated in Kidney Transplantation (KT), i.e. predictive of post-KT complications: delayed recovery of graft function, graft function, early re-hospitalization, occurrence of post-operative confusion, mortality. Fragile patients present at least 3 out of 5 criteria
Biological: Blood sample · Behavioral: Geriatric assessment standardized
Patients will be considered non-fragile if they present 0 to 2 criteria
Biological: Blood sample · Behavioral: Geriatric assessment standardized
* Immunophenotyping of peripheral lymphocytes, with a focus on proportions of naïve / central memory / effector memory / TEMRA cells, and markers of activation and senescence * Serum inflammatory markers : CRP, IL-6, MCP-1, TNF, sTNFR1 * Single Molecule Array for IL1 and LUMINEX for IL18 in patient's sera * RT-qPCR for inflammasomes genes (NLRP3, NLRC4, NLRC5, AIM2, ASC, casp1, IL1b, IL18) expression among peripheral blood mononuclear cells * Assembly of the inflammasome platform will be measured in monocytes using intra-cellular staining of the ASC protein and flow cytometry
* Exhaustion (2 standardized questions) * Physical activity \<383 kcal/week (men) or \<270 kcal/week (women), measured using a standardized questionnaire (IPAQ) * 4-meters gait speed, with sex and height-specific cutoffs * Handgrip strength, measured using a dynamometer, with sex and BMI-sp Comorbidity (CIRS-G score ) * Screening for intrinsic capacity decline (first step of ICOPE program, adapted to the study, ) * Physical performance (SPPB score ) * Cognitive functions (MoCA score ), * Depression (GDS-15 score ), * Nutrition (MNA score ) * Sensory functions (Snellen test for vision, HHIES questionnaire for hearing) -- Dependency in activities of daily living (ADL and IADL scores)
IL1
Single Molecule Array for IL1
Time frame: at recruitment (up to 30 days)
IL18
LUMINEX for IL18 in patient's sera
Time frame: at recruitment (up to 30 days)
inflammasomes genes
RT-qPCR for inflammasomes genes (NLRP3, NLRC4, NLRC5, AIM2, ASC, casp1, IL1b, IL18) expression among peripheral blood mononuclear cells
Time frame: at recruitment (up to 30 days)
inflammasome platform
Assembly of the inflammasome platform will be measured in monocytes using intra-cellular staining of the ASC protein and flow cytometry
Time frame: at recruitment (up to 30 days)
Weight
Frailty phenotype : Weight loss (unintentional, \>4,5 kg during past year)
Time frame: at enrollment (Day 0), at recruitment (up to 30 days)
Activity
Frailty phenotype : Physical activity \<383 kcal/week (men) or \<270 kcal/week (women), measured using a standardized questionnaire (IPAQ)
Time frame: at enrollment (Day 0), at recruitment (up to 30 days)
Gait
Frailty phenotype : 4-meters gait speed, with sex and height-specific cutoffs
Time frame: at enrollment (day 0), at recruitment (up to 30 days)
Handgrip strength
Frailty phenotype : Handgrip strength, measured using a dynamometer, with sex and BMI-specific cutoffs
Time frame: at enrollment (day 0), at recruitment (up to 30 days)
Comorbidity
Comorbidity : Cumulative Illness Rating Scale (CIRS-G score)
Time frame: at recruitment (up to 30 days)
decline
Screening for intrinsic capacity decline : first step of ICOPE program, adapted to the study
Time frame: at recruitment (up to 30 days)
Physical performance
Physical performance : Short Physical Performance Battery (SPPB) score. The SPPB (Short Physical Performance Battery) is the sum of scores on three criteria: the balance test, the walking speed test and the chair lift test. This test assesses an individual's physical performance. The sum of the scores for all the tests gives an overall performance score. A score below 8 indicates a risk of sarcopenia (or age-related muscular dystrophy).
Time frame: at recruitment (up to 30 days)
Cognitive functions
Cognitive functions : Score Montreal Cognitive Assessment (MoCA) score The Montreal Cognitive Assessement (MoCA) is the most sensitive rapid assessment test, providing the most comprehensive evaluation (attention, concentration, executive functions, memory, language, capacitive-vesuo-constructive, abstraction, calculation, orientation) cognitive functions. It is tending to replace the MMSE in clinical practice. A score of 26 (25 if cultural level ≤3 = primary diploma = CEP) is considered abnormal.
Time frame: at recruitment (up to 30 days)
Depression
Depression : Geriatric Depression Scale (GDS-15 score) 0 - 5 points: normal 5-10 points: mild to moderate depression 11-15 points: severe depression
Time frame: at recruitment (up to 30 days)
Nutrition
Nutrition : Mini Nutritional Assessment (MNA score) * 12-14 points: MNA score indicates normal nutritional status. * 8-11 points: the MNA score indicates a risk of malnutrition. * 0-7 points: MNA score indicates malnutrition.
Time frame: at recruitment (up to 30 days)
Snellen test
Sensory functions : Snellen test for vision
Time frame: at recruitment (up to 30 days)
ADL
Dependency in activities of daily living : Activities of Daily Living ADL The original ADL scale scores each of the 6 items in 0/1, with 1 corresponding to independence and 0 to dependence. The total score ranges from 0 to 6. An overall score can be calculated, ranging from 0 (totally dependent) to 6 (best possible independence).
Time frame: at recruitment (up to 30 days)
Immunophenotyping
Immunophenotyping of peripheral lymphocytes, with a focus on proportions of naïve / central memory / effector memory / TEMRA cells, and markers of activation and senescence
Time frame: at recruitment (up to 30 days)
CRP
Serum inflammatory markers : CRP
Time frame: at recruitment (up to 30 days)
IL-6
Serum inflammatory markers : IL-6
Time frame: at recruitment (up to 30 days)
MCP-1
Serum inflammatory markers : MCP-1
Time frame: at recruitment (up to 30 days)
TNF
Serum inflammatory markers : TNF
Time frame: at recruitment (up to 30 days)
sTNFR1
Serum inflammatory markers : sTNFR1
Time frame: at recruitment (up to 30 days)
HHIES questionnaire
Sensory functions : Hearing Handicap Inventory for the Elderly Screening (HHIES) questionnaire for hearing. The higher the score, the greater the likelihood of hearing loss
Time frame: at recruitment (up to 30 days)
IADL
Dependency in activities of daily living : IADL scores
Time frame: at recruitment (up to 30 days)
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University Hospital, Bordeaux