Clinical Trials Register

Summary
EudraCT Number:	2017-002450-37
Sponsor's Protocol Code Number:	IOEX2017
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-07
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-002450-37

A.3

Full title of the trial

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

Funzione renale nell'anziano sarcopenico a bassa creatinina. Valutazione del filtrato glomerulare con il metodo dello Ioexolo.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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).

Valutazione della funzione renale nel paziente anziano con ridotta massa e performance muscolare e bassi valori di creatinina sierica, con conseguente rischio di sovrastima della funzione renale: si confronta un metodo di misura esatta del filtrato glomerulare (cioè del parametro utilizzato per valutare la funzione renale) con la stima dello stesso, mediante specifiche equazioni.

A.3.2

Name or abbreviated title of the trial where available

Renal function evaluation with iohexol method

Studio della funzione renale con il metodo dello ioexolo

A.4.1

Sponsor's protocol code number

IOEX2017

A.5.4

Other Identifiers

Name:

Ioexolo

Number:

IOEX2017

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Università degli Studi di Firenze
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliero-Universitara di Careggi
B.5.2	Functional name of contact point	DAI Medico-Geriatrico - Geriatria U
B.5.3	Address:
B.5.3.1	Street Address	L.go Brambilla, 3
B.5.3.2	Town/ city	Firenze
B.5.3.3	Post code	50134
B.5.3.4	Country	Italy
B.5.4	Telephone number	055 7949429
B.5.5	Fax number	055 2758126
B.5.6	E-mail	aungar@unifi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	GE HEALTHCARE S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Omnipaque 300 mg/mL
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Elderly sarcopenia patients with low serum creatinine and suspected chronic kidney disease

Paziente anziano sarcopenico, con bassi valori di creatinina sierica e sospetta insufficienza renale cronica

E.1.1.1

Medical condition in easily understood language

Elderly patients with low serum creatinine and reduced muscle mass, where creatinine based equations probably provide an over-estimate of renal function

Pazienti anziani con bassi valori di creatina sierica e massa muscolare ridotta, per cui si sopetta una sovrastima della funzione renale, se valutata mediante equazioni basate sulla creatinina

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10009119
E.1.2	Term	Chronic renal failure
E.1.2	System Organ Class	100000004857

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10063024
E.1.2	Term	Sarcopenia
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To identify the most precise equation for the estimate of renal function in our specific population, including elderly patients with sarcopenia.

Fra le formule oggi disponibili per il calcolo del filtrato glomerulare a partire da parametri clinici e caratteristiche biologiche del soggetto, identificare quella che garantisce il livello di precisione maggiore, in questa popolazione specifica, di anziani con sarcopenia.

E.2.2

Secondary objectives of the trial

None

Nessuno

E.2.3

Trial contains a sub-study

E.3

Principal 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

1. Età = 65 anni
2. Valori di creatinina sierica = 1,0 mg/dL
3. Presenza di sarcopenia definita come (2 criteri su 3):
- Ridotta massa muscolare, misurata con bioimpedenziometria (BIA), standardizzando per BMI (kg/m2)
- Ridotta forza muscolare, misurata con Handgrip < 30 kg (nell’uomo) e < 20 kg (nella donna)
- Ridotta performance muscolare, valutata tramite Short Physical Performance Battery (SPPB)< 9/12 o, dove non applicabile la scala SPPB per le condizioni cliniche del paziente, ci si baserà sul dato anamnestico di ridotta velocità del cammino
4. Firma del consenso informato da parte del paziente o del legale tutore

E.4

Principal 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

1. Allergia documentata o riferita al mezzo di contrasto iodato o agli eccipienti del farmaco
2. Controindicazioni assolute all’assunzione del farmaco (ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti, tireotossicosi conclamata, reazioni gravi a Omnipaque in anamnesi)
3. Recente esame con mezzo di contrasto iodato (=4 giorni)

E.5 End points

E.5.1

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.

- Il valore di filtrato glomerulare misurato con lo ioexolo. Contestualmente si procederà al calcolo del valore del filtrato glomerulare, utilizzando le 6 formule di stima oggi disponibili. Le informazioni necessarie per procedere al calcolo delle stime sono rappresentate da: età in anni, sesso ed etnia del soggetto, valore di creatinina e cistatina C sieriche. Per quanto riguarda il valori di creatinina e cistatina C sieriche, verranno raccolti valori ottenuti attraverso un prelievo di sangue di 5-10 mL, che viene routinariamente eseguito come monitoraggio della funzionalità renale in questo tipo di pazienti, effettuato nelle 24 ore precedenti o successive allo studio dello ioexolo.

E.5.1.1

Timepoint(s) of evaluation of this end point

One day

Un giorno

E.5.2

Secondary end point(s)

Not applicable

Non applicabile

E.5.2.1

Timepoint(s) of evaluation of this end point

None

Nessuno

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

if affected by dementia

se affetti da demenza

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The patient will undergo clinical observation in the hospital for the 24 hours following iohexol administration.
The measured glomerular filtration rate value will be communicated to the participants.

Osservazione per le 24 ore successive l'esecuzione dell'esame. Una volta disponibile, ai soggetti partecipanti verrà comunicato il valore di filtrato glomerulare ottenuto con il metodo dello ioexolo.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-11

P. End of Trial
P.	End of Trial Status	Ongoing

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