Renal function evaluation in the elderly with reduced muscle mass and low serum creatinine, with a consequent risk of over-estimate of renal function: comparison between direct measurement and estimate of glomerular filtration rate (a parameter evaluating renal function).

Renal function evaluation through iohexol method in the elderly with sarcopenia and low serum creatinine - Renal function evaluation with iohexol method

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002450-37-IT

Enrollment

Registered

2021-09-07

Start date

2018-12-11

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly sarcopenia patients with low serum creatinine and suspected chronic kidney disease MedDRA version: 21.1 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857 MedDRA version: 20.1 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML Product Name: Omnipaque 300 mg/mL Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 65 years old 2. Serum creatinine = 1.0 mg/dL 3. Presence of sarcopeny, defined as (at least 2 criteria): - lower muscle mass (detected with bioimpedenziometry, BIA, after standardization with BMI - lower muscle strenght (Handgrip =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1. Allergy or hypersensitivity to contrast agent or drug excipients 3. Contraindications to the administration of iohexol (hypersensitivity to the active substance or to drug excipients; thyrotoxicosis; previous adverse reactions to iohexol administration) 4. Diagnostic procedures using iodinated contrast agent over the previous four days

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the most precise equation for the estimate of renal function in our specific population, including elderly patients with sarcopenia.;Secondary Objective: None;Primary end point(s): - The measured glomerular filtration rate (GFR) using iohexol method. At the same time, GFR was estimated using the following formulas: MDRD, CKD- EPIcreatinine, CKD-EPIcreatinine-cystatinC, CKD-EPIcystatinC, BIS-1 and BIS-2. These formulas are based on patient's age, sex and race, and are based on serum creatinine and cystatin C values, obtained in the 24 hours previous or following the application of the iohexol method, depending on the choice of the attending physician.;Timepoint(s) of evaluation of this end point: One day	—

Measure

Time frame

Main Objective: To identify the most precise equation for the estimate of renal function in our specific population, including elderly patients with sarcopenia.;Secondary Objective: None;Primary end point(s): - The measured glomerular filtration rate (GFR) using iohexol method. At the same time, GFR was estimated using the following formulas: MDRD, CKD- EPIcreatinine, CKD-EPIcreatinine-cystatinC, CKD-EPIcystatinC, BIS-1 and BIS-2. These formulas are based on patient's age, sex and race, and are based on serum creatinine and cystatin C values, obtained in the 24 hours previous or following the application of the iohexol method, depending on the choice of the attending physician.;Timepoint(s) of evaluation of this end point: One day

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: None	—

Countries

Italy

Contacts

Public ContactDAI Medico-Geriatrico - Geriatria U

Azienda Ospedaliero-Universitara di Careggi

aungar@unifi.it055 7949429

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026