Clinical Trials Register

Summary
EudraCT Number:	2012-000171-17
Sponsor's Protocol Code Number:	SPD405-207
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-12
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2012-000171-17

A.3

Full title of the trial

A Three Part Open-Label Study to Assess the Pharmacokinetics of A 3-part Open-label Study to Assess the Pharmacokinetics of
Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate using a Crossover design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 years to <18 Years With Chronic Kidney Disease on Dialysis

A.3.1

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

A study to compare treatment for hyperphosphataemia in children suffering from renal failure with a new product called Lanthanum oral powder with an established treatment called calcium carbonate.

A.4.1

Sponsor's protocol code number

SPD405-207

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/232/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Shire Pharmaceutical Development Ltd.
B.1.3.4	Country	United Kingdom
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	Shire Pharmaceutical Development Ltd.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire Pharmaceutical Development Ltd.
B.5.2	Functional name of contact point	Global Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Hampshire International Business Park, Chineham
B.5.3.2	Town/ city	Basingstoke, Hampshire
B.5.3.3	Post code	RG24 8EP
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	441256890000
B.5.6	E-mail	medaffairseuceemea@shire.com

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	No
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	Fosrenol Oral Powder 250mg
D.3.2	Product code	SPD405
D.3.4	Pharmaceutical form	Oral powder
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	54451-24-0
D.3.9.2	Current sponsor code	SPD405-207
D.3.9.3	Other descriptive name	LANTHANUM CARBONATE
D.3.9.4	EV Substance Code	SUB21835
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Calcichew 500mg Chewable Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda UK Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Calcichew 500mg Chewable Tablets
D.3.2	Product code	SPD-406
D.3.4	Pharmaceutical form	Chewable 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.3.9.1	CAS number	471-34-1
D.3.9.3	Other descriptive name	CALCIUM CARBONATE
D.3.9.4	EV Substance Code	SUB13166MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	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

Treatment of Hyperphosphataemia.

E.1.1.1

Medical condition in easily understood language

Hyperphosphataemia in chronic kidney disease is caused by decreased excretion of phosphorus by kidneys.

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020712
E.1.2	Term	Hyperphosphatemia
E.1.2	System Organ Class	100000004861

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 summarize the percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum
phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following 8 weeks of
treatment with lanthanum carbonate.

E.2.2

Secondary objectives of the trial

1. To investigate the safety profile in hyperphosphatemic children and adolescents with CKD on dialysis treated with calcium carbonate and/or lanthanum carbonate.
2. To summarize the percentage of subjects achieving KDOQI targets for serum phosphorus in hyperphosphatemic children and adolescents with CKD who are on dialysis following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.
3. To assess mean changes from baseline in serum phosphorus, calcium and calcium-phosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks.
4. To summarize mean changes from baseline in serum phosphorus, calcium and calcium-phosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged 10 yesrs to < 18 years of age at the time of consent.

2. Subject and parent or legally authorized representative (LAR) understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.

3. Male, or non pregnant, non lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.

4. Established CKD, on dialysis and requires treatment for hyperphosphataemia with a phosphate binder.

5. Serum phosphorus levels after a washout period of up to 3 weeks as follows:

• Age <12 years: Serum phosphorus > 6.0mg/dL (1.94mmol/L).

• Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L).

6. Ability to provide written, signed, and dated (personally or via a legally acceptable representative) informed consent/and assent, as applicable, to participate in the study.

E.4

Principal exclusion criteria

Subjects are excluded from the study if any of the following criteria are met:
1. Current or recurrent disease (e.g., cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
2. Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or end-stage renal disease and related co-morbidities) that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
3. Unable to eat semi-solid foods or on Total Enteral Alimentation.
4. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
5. History of alcohol or other substance abuse within the last year.
6. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.( Current use is defined as use within 1 day) See Section 5 ( Prior and Concomitant Treatment) for a list of prohibited and restricted medications.
7. Weight and age of subject are outside local applicable criteria for blood sample volume limits.
8. Use of another investigational product within 30 days prior to receiving the first dose of investigational product.

E.5 End points

E.5.1

Primary end point(s)

The percentage of subjects with serum phosphorus levels below the age-specific KDOQI targets following 8-weeks of treatment with calcium carbonate and lanthanum carbonate (Part 2 of the study).

The KDOQI serum phosphorus targets are defined as:

‒ Adolescents aged ≥12-<18 years: ≤5.5mg/dL (1.78mmol/L).

‒ Children aged 6 months -<12 years: ≤6.0mg/dL (1.94mmol/L).

For the primary endpoint, the percentage of subjects achieving age-specific KDOQI targets for serum phosphate levels after 8 weeks of lanthanum carbonate treatment will be descriptively summarized and calculated along with a 95% confidence interval. The FAS and PP2 Sets will be used for this descriptive summarization. Serum phosphate levels tested at a central laboratory will be used for the analysis. In the case of missing central laboratory data, local laboratory data will be used.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of Part 2

E.5.2

Secondary end point(s)

• The percentage of subjects with serum phosphorus levels below the age-specific KDOQI targets following 8 weeks of treatment with calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate will be descriptively summarized and will be calculated along with a 95% confidence interval, separately, for each treatment arm. The FAS and PP1 Sets will be used for this summarization. The KDOQI serum phosphorus targets are defined as:
- Adolescents aged ≥12-<18 years: ≤5.5 mg/dL (1.78 mmol/L)
- Children aged 10 years -<12 years: ≤6.0 mg/dL (1.94 mmol/L)
• Changes from baseline in serum phosphorus, calcium and calciumphosphorus product in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks.
• Change from baseline in serum phosphorus, calcium and calciumphosphorus product levels at the last visit of each 8 week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3).
• Biochemical bone markers: bone ALP, osteocalcin, TRAP, FGF-23, PTH, sclerostin and fetuin-A before and after each treatment period in Part 2,
and at the end of Part 3.
• Height and weight at:
o Visits 2.0, 2.4, 2.8, and 3.5 (Parts 2a and 3)
o Visits 1.0, 2.4, and 3.5 (Parts 2b and 3).

E.5.2.1

Timepoint(s) of evaluation of this end point

End of Part 3

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Tolerability.

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

Yes

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

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Chile

Czech Republic

Germany

Hungary

India

Poland

Romania

Russian Federation

South Africa

Turkey

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

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

Yes

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

Subjects are paediatrics.

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)

Not applicable

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

2013-01-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-11-16

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