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).

Phase 1

• Conditions: Elderly sarcopenia patients with low serum creatinine and suspected chronic kidney disease; MedDRA version: 21.1Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857; MedDRA version: 20.1Level: PTClassification code 10063024Term: SarcopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2017-002450-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 < 20 kg in females and < 30 kg in males)
- lower muscle performance, detected with Short Physical Performance Battery (SPPB), where available.
4. Patient accepts to take part to the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: None