Clinical Trials Register

Summary
EudraCT Number:	2005-004643-53
Sponsor's Protocol Code Number:	20050104
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2006-06-23
Trial results	View 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

2005-004643-53

A.3

Full title of the trial

Bone Histomorphometry Assessment For Incident Dialysis Patients with Secondary Hyperparathyroidism of End Stage Renal Disease
(BONAFIDE STUDY)

Valutazione istomorfometrica dell'osso in Pazienti in dialisi con iperparatiroidismo secondario dovuto a malattia renale allo stadio finale (Studio BONAFIDE)

A.3.2

Name or abbreviated title of the trial where available

(BONAFIDE STUDY)

A.4.1

Sponsor's protocol code number

20050104

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	AMGEN S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	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
B.5.2	Functional name of contact point

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	MIMPARA*28CPR RIV 30MG
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN SpA *
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.3.4	Pharmaceutical form	Film-coated tablet
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	CINACALCET
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	30
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Non Applicabile
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	MIMPARA*28CPR RIV 60MG
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN SpA *
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.3.4	Pharmaceutical form	Film-coated tablet
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	CINACALCET
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	60
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Non Applicabile
D.IMP: 3
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	MIMPARA*28CPR RIV 90MG
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN SpA *
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.3.4	Pharmaceutical form	Film-coated tablet
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	CINACALCET
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	90
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Non Applicabile

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

Secondary hyperparathyroidism (HPT) in subjects with
CKD receiving dialysis.

Iperparatiroidismo Secondario (HPT) in soggetti in dialisi con insufficienza renale cronica.

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10038359
E.1.2	Term	Renal and urinary disorders
E.1.2	System Organ Class	10038359 - Renal and urinary 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 describe histomorphometric parameters of bone
turnover in incident dialysis subjects with high turnover
renal osteodystrophy during treatment with
Sensipar/Mimpara with or without concomitant vitamin
D sterols and/or phosphate binders therapy.
Secondary

Valutare gli effetti di un regime terapeutico per la cura dell' iperparatiroidismo secondario, composto da Sensipar/Mimpara con o senza vitamina D e/o leganti del fosfato, sui parametri istomorfometrici del turnover osseo in pazienti in dialisi con osteodistrofia renale ad elevato turnover.

E.2.2

Secondary objectives of the trial

To evaluate:
• The effects of Sensipar/Mimpara on bio-intact
parathyroid hormone (biPTH), intact parathyroid
hormone (iPTH), bone-specific alkaline
phosphatase (BALP), osteocalcin (OC), serum Ntelopeptide
(NTx), deoxypyridinoline (DPD), and
tartrate resistant acid phosphatase (TRAP)
• The effects of Sensipar/Mimpara on serum
calcium, serum phosphorus, and Ca x P
concentrations
-The safety and tolerability of Sensipar/Mimpara
including its effect on mineralization lag time,
osteoid area/volume, osteoid width/thickness,
and the incidence of adynamic bone disease.

Valutare:
-Gli effetti di Sensipar/Mimpara sull'ormone paratiroideo bio-intatto (biPTH),sull'ormone paratiroideo intatto (iPTH),sulla fosfatasi alcalina specifica dell'osso (BALP),sull'osteocalcina (OC),sull' N-telopeptide sierico (NTx),sulla desossipiridinolina (DPD),e sulla fosfatasi acida tartrato resistente (TRAP).
-Gli effetti di Sensipar/Mimpara sul calcio sierico,sul fosforo sierico,e sulle concentrazioni di Ca x P
-La sicurezza e la tollerabilita' di Sensipar/Mimpara,inclusi i suoi effetti sulle tempistiche di rallentamento della mineralizzazione,su area/volume dell' osteoide e su ampiezza/spessore dell'osteoide

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Men or women ≥ 18 years of age at screening.
Agree to use, in the opinion of the principal investigator, highly effective
contraceptive measures throughout the study.
One biPTH determination obtained from the central laboratory must be ≥ 160
pg/mL (17.0 pmol/L).
One serum calcium determination obtained from the central laboratory must be ≥
8.4 mg/dL (2.1 mmol/L).
One BALP determination obtained from the central laboratory must be > 20.9
ng/mL.
Positive histologic confirmation of high bone turnover disease. Positive
confirmation is defined as any of the following:
• Osteoid area < 12%, BFR > 613 µm2/mm2/day, and no evidence of
fibrosis
• Osteoid area < 12%, BFR > 97 µm2/mm2/day, and evidence of fibrosis
• Osteoid area > 12%, BFR > 97 µm2/mm2/day, with or without evidence of
fibrosis
Treated with dialysis for ≥ 1 month and ≤ 6 months before the date of informed
consent.
Ethical - Before any study-specific procedure, the appropriate written informed
consent must be obtained (see Section 13.1).

Soggetti con eta' ≥ di 18 anni al momento dello screening
Soggetti concordi ad utilizzare un efficace metodo contraccettivo per tutta la durata dello studio
Soggetti con un valore di biPTH, ottenuta dal laboratorio centralizzato, che sia ≥ 160 pg/ml (17.0 pmol/l)
Soggetti con un livello di calcio sierico, ottenuta dal laboratorio centralizzato, che sia ≥ 8.4 mg/dl (2.1 mmol/L)
Soggetti con un livello di fosfatasi alcalina specifica dell'osso (BALP), ottenuta dal laboratorio centralizzato, che sia ≥ 20.9 ng/ml
Conferma istologica positiva della malattia da elevato turnover osseo definita basandosi sui seguenti criteri:
· Area osteoide < 12 %, velocita' di formazione dell'osso (BFR) > 613 μm2/mm2/al di', e assenza di fibrosi
· Area osteoide < 12 %, BFR > 97 μm2/mm2/al di', e fibrosi
Area osteoide > 12 %, BFR > 97 μm2/mm2/al di', con o senza fibrosi
Soggetti in dialisi per un periodo ≥ 1 mese e  6 mesi prima della firma del Consenso Informato
Ottenimento del Consenso Informato scritto prima di effettuare qualsiasi procedura di studio

E.4

Principal exclusion criteria

Have an unstable medical condition in the judgment of the investigator.
Are pregnant or nursing women.
Had a parathyroidectomy in the 3 months before the date of informed consent.
For subjects prescribed vitamin D, have received vitamin D therapy for less than
30 days before day 1 or required a change in vitamin D brand or dose level within
30 days before day 1.
Received within 30 days before day 1, therapy FORTEOTM.
Ever received therapy with Sensipar/Mimpara
Ever received therapy with bisphosphonates
General

Soggetti con una condizione medica non stabile, a giudizio dello Sperimentatore
Donne in gravidanza o in allattamento
Soggetti che hanno effettuato un intervento di paratiroidectomia nei tre mesi antecedenti alla firma del Consenso informato
Per i soggetti che assumono vitamina D, non sono eleggibili i soggetti che la assumono o che richiedono un cambio di dose nel periodo dei 30 giorni prima del giorno 1 (inizio trattamento)
Soggetti che assumono Forteo nei 30 giorni precedenti al giorno 1 (inizio trattamento)
Soggetti che hanno gia' assunto Sensipar/Mimpara
Soggetti che hanno assunto Bifosfonati
Altro

E.5 End points

E.5.1

Primary end point(s)

Secondari:
Variazione del numero di osteoblasti ed osteoclasti attivi rispetto al basale. Variazione della superficie erosa e della superficie fibrotica rispetto al basale.
Variazione percentuale di biPTH, iPTH, BALP, OC, NTx sierico, DPD e TRAP rispetto al basale.
Cambiamento percentuale del calcio , del fosforo sierico e delle concentrazioni di Ca x P, rispetto al basale.

Primario:
Cambiamenti nella velocita' di formazione dell'osso rispetto al basale (BFR).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.2.3.1

Comparator description

Titolazione farmaco efficacia a diversi dosaggi

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

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	12
F.4.2	For a multinational trial
F.4.2.1	In the EEA	50
F.4.2.2	In the whole clinical trial	85

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

2006-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-02-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-05-13

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