Clinical Trials Register

Summary
EudraCT Number:	2019-004840-30
Sponsor's Protocol Code Number:	PrepDial
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:	2020-10-21
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

2019-004840-30

A.3

Full title of the trial

Comparison of low-volume versus high-volume polyethylene glycol based bowel preparation for colonoscopy in people receiving hemodialysis: a randomized non-inferiority trial.

Confronto tra preparazione intestinale per la colonscopia a base di polietilenglicole a basso volume e ad alto volume in soggetti sottoposti a emodialisi: uno studio randomizzato di non inferiorità.

A.3.1

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

Comparison of two different volumes of colonoscopy fluid in hemodialysis patients: randomized non-inferiority study.

Confronto tra due diversi volumi di liquido per colonscopia in pazienti sottoposti a emodialisi: studio randomizzato di non inferiorità.

A.3.2

Name or abbreviated title of the trial where available

PrepDial

A.4.1

Sponsor's protocol code number

PrepDial

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	Policlinico di Bari-UO Gastroenterologia
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Policlinico di Bari
B.5.2	Functional name of contact point	UO Gastroenterologia
B.5.3	Address:
B.5.3.1	Street Address	P.zza Giulio Cesare 11
B.5.3.2	Town/ city	Bari
B.5.3.3	Post code	70124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0805592577
B.5.6	E-mail	alfredo.dileo@uniba.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	Clensia
D.2.1.1.2	Name of the Marketing Authorisation holder	Alfasigma S.p.A
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	Clensia
D.3.2	Product code	[Clensia]
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MACROGOL 4000
D.3.9.2	Current sponsor code	Clensia
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	52
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	Yes
D.3.11.13.1	Other medicinal product type	polyethylene glycol based bowel preparation for colonoscopy
D.IMP: 2
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	SELG ESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	Alfasigma S.p.A.
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	Selg Esse
D.3.2	Product code	[Selg Esse]
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MACROGOL 4000
D.3.9.2	Current sponsor code	selg esse
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	58
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	Yes
D.3.11.13.1	Other medicinal product type	liquido per colonscopia

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

Colonoscopy in people receiving hemodialysis

Colonscopia in pazienti in emodialisi

E.1.1.1

Medical condition in easily understood language

Patients who need to undergo an instrumental colon examination who already receive physical therapy to replace kidney function

Pazienti che devono sottoporsi ad un esame strumentale del colon che già ricevono una terapia fisica sostitutiva della funzionalità renale

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	HLT
E.1.2	Classification code	10053099
E.1.2	Term	Gastrointestinal function diagnostic procedures
E.1.2	System Organ Class	100000004848

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study will be to assess the non-inferiority of a low-volume compared with a high-volume polyethylene glycol based bowel preparation for adequate bowel cleansing in people on hemodialysis

L'obiettivo principale dello studio sarà valutare la non inferiorità di un volume basso rispetto a una preparazione intestinale a base di glicole polietilenico ad alto volume per un'adeguata pulizia intestinale nelle persone in emodialisi

E.2.2

Secondary objectives of the trial

The secondary objectives will include the comparison of the two cleansing agents on other endoscopic and nephrologic relevant clinical outcomes (adenoma detection rate, cecal intubation rate, participants’ compliance, participants’ tolerability, willingness to repeat the preparation, adverse events, hospitalization, supplementary hemodialysis sessions, hemodialysis performance measures).

Gli obiettivi secondari includeranno il confronto dei due agenti detergenti su altri risultati clinici rilevanti endoscopici e nefrologici (tasso di rilevazione dell'adenoma, tasso di intubazione cecale,aderenza dei partecipanti, tollerabilità dei partecipanti, disponibilità a ripetere la preparazione, eventi avversi, ricovero, emodialisi supplementare, misure di prestazione dell'emodialisi).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- age =18 years;
- prevalent end stage kidney disease treated with long-term hemodialysis (hemodialysis for at least 6 months; either hemodialysis or hemofiltration or hemodiafiltration, received for at least 3 times/week for a minimum duration of 4 hours per treatment session for a minimum of 12 hours/week, according to standard practice for quality hemodialysis in Italy);
- inpatients and outpatients with an indication to undergo colonoscopy (e.g. positive fecal occult blood test or fecal immunochemical test, signs or symptoms of colorectal disease, colorectal cancer screening, colorectal cancer surveillance, inflammatory bowel diseases, or inclusion in kidney transplantation waiting list);
- signature of written informed consent.

- età =18 anni;
- malattia renale allo stadio terminale trattata con emodialisi a lungo termine (emodialisi per almeno 6 mesi; emodialisi o emofiltrazione o emodiafiltrazione, per almeno 3 volte a settimana per una durata minima di 4 ore per sessione di trattamento per un minimo di 12 ore / settimana, secondo la pratica standard per l'emodialisi in Italia);
- pazienti ricoverati e ambulatoriali con un'indicazione per sottoporsi a colonscopia (ad es. esame del sangue occulto fecale positivo o test immunochimico fecale, segni o sintomi di malattia colorettale, screening del cancro del colon-retto, sorveglianza del cancro del colon-retto, malattie infiammatorie intestinali o inclusione nella lista di attesa del trapianto di rene);
- firma del consenso informato scritto.

E.4

Principal exclusion criteria

- end stage kidney disease not on hemodialysis (eg. peritoneal dialysis or kidney transplantation);
- previous kidney transplantation;
- need for colonoscopy in emergency;
- previous colorectal surgery;
- contraindications to colonoscopy in the opinion of the managing physician;
- pregnancy or breastfeeding;
- known or suspected hypersensitivity to any components of preparations.

- malattia renale allo stadio terminale non in emodialisi (es. dialisi peritoneale o trapianto renale);
- precedente trapianto di rene;
- necessità di colonscopia in caso di emergenza;
- precedente chirurgia colorettale;
- controindicazioni alla colonscopia secondo il parere del medico curante;
- gravidanza o allattamento;
- ipersensibilità nota o sospetta a qualsiasi componente dei preparati.

E.5 End points

E.5.1

Primary end point(s)

The primary outcome will be the proportion of participants with adequate bowel cleansing, evaluated using the Boston Bowel Preparation Scale. This standardized tool classifies the quality of bowel preparation for each colonic segment (right, transverse, and left colon) from 0 (very poor) to 3 (excellent), with the total score ranging from 0 to 9.Adequate bowel preparation will be defined as a total score =6 with each segmental score =2.

L'end point primario sarà la percentuale di partecipanti con un'adeguata pulizia dell'intestino, valutata usando la Boston Bowel Preparation Scale. Questo strumento standardizzato classifica la qualità della preparazione intestinale per ciascun segmento del colon (colon destro, trasversale e sinistro) da 0 (molto scarso) a 3 (eccellente), con un punteggio totale compreso tra 0 e 9. Verrà definita un'adeguata preparazione intestinale come punteggio totale =6 con ciascun punteggio segmentale =2.

E.5.1.1

Timepoint(s) of evaluation of this end point

13 months

13 mesi

E.5.2

Secondary end point(s)

- adenoma detection rate, defined as the proportion of participants with one or more adenoma detected during colonoscopy;
- cecal intubation rate, defined as the proportion of participants with complete endoscopic examination (i.e. colonoscopy reaching the cecum);
- participants’ compliance, defined as the proportion of participants taking =75% of the bowel preparation;
- participants’ tolerability, defined as the proportion of participants with gastrointestinal symptoms known to be related to bowel cleansing agents intake (i.e. presence of nausea, bloating, vomiting, abdominal pain, and anal irritation). Each symptom will also be graded as absent, mild, moderate or severe;
- participants’ willingness to repeat the preparation, defined as the proportion of participants willing to use the same bowel preparation for future examinations;
- adverse events, defined as the proportion of participants experiencing any event occurred during the intake of bowel preparation (e.g. thrombosis of dialysis access, hypo/hypernatremia, hypo/hypercalcemia, hypo/hyperkalaemia, hypo/hyperphosphoremia, muscle cramps, among others);
- all-cause hospitalization, defined as the proportion of participants requiring hospitalization for any cause;
- all-cause mortality, defined as the proportion of participants dead for any cause;
- emergency hemodialysis sessions, defined as the proportion of participants requiring one or more additional hemodialysis sessions;
- cardiovascular events, defined as the proportion of participants experiencing cardiovascular complications (i.e. nonfatal myocardial infarction, acute coronary syndrome, or heart failure);
- hemodialysis performance measures, including interdialytic body weight gain, variations in serum-electrolyte levels, pre- and post-dialysis systolic blood pressure, pre- and post-dialysis diastolic blood pressure, and blood flow on dialysis.

- tasso di rilevamento dell'adenoma, definito come la percentuale di partecipanti con uno o più adenomi rilevati durante la colonscopia;
- tasso di intubazione cecale, definito come la percentuale di partecipanti con esame endoscopico completo (cioè colonscopia che raggiunge il cieco);
- conformità dei partecipanti, definita come la percentuale di partecipanti che prende =75% della preparazione intestinale;
- tollerabilità dei partecipanti, definita come la percentuale di partecipanti con sintomi gastrointestinali noti per essere correlati all'assunzione di detergenti intestinali (ovvero presenza di nausea, gonfiore, vomito, dolore addominale e irritazione anale). Ogni sintomo verrà anche classificato come assente, lieve, moderato o grave;
- la volontà dei partecipanti di ripetere la preparazione, definita come la percentuale di partecipanti disposti a utilizzare la stessa preparazione intestinale per esami futuri;
- eventi avversi, definiti come la percentuale di partecipanti che hanno manifestato qualsiasi evento durante l'assunzione della preparazione intestinale (ad es. trombosi dell'accesso alla dialisi, ipo / ipernatremia, ipo / ipercalcemia, ipo / ipercaliemia, ipo / iperfosforofemia, crampi muscolari, tra gli altri);
- ricovero per tutte le cause, definito come la percentuale di partecipanti che richiedono il ricovero per qualsiasi causa;
- mortalità per qualsiasi causa, definita come la percentuale di morti per qualsiasi causa;
- sessioni di emodialisi di emergenza, definite come la percentuale di partecipanti che richiedono una o più sessioni di emodialisi aggiuntive;
- eventi cardiovascolari, definiti come la percentuale di partecipanti con complicanze cardiovascolari (cioè infarto miocardico non fatale, sindrome coronarica acuta o insufficienza cardiaca);
- misure di prestazione dell'emodialisi, incluso aumento del peso corporeo interdialitico, variazioni dei livelli sierici di elettroliti, pressione arteriosa sistolica pre e post dialisi, pressione arteriosa diastolica pre e post dialisi e flusso sanguigno in dialisi.

E.5.2.1

Timepoint(s) of evaluation of this end point

13 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

Yes

E.6.13.1

Other scope of the trial description

assess the non-inferiority of a low-volume compared with a high-volume polyethylene glycol based bowel preparation for adequate bowel cleansing in people on hemodialysis

valutare la non inferiorità di un volume basso rispetto a una preparazione intestinale a base di glicole polietilenico ad alto volume per un'adeguata pulizia intestinale nelle persone in emodialisi

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

Volume diverso di liquido intestinale

Different volume of intestinal liquid

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.8.6 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)

Yes

F.1.2.1

Number of subjects for this age range:

264

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

264

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

264

F.4.2

For a multinational trial

F.4.2.1

In the EEA

264

F.4.2.2

In the whole clinical trial

264

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)

Non previsto

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

2020-09-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-04

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

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