Phase 2/3, twelve-month, multicenter, intra-subjectcontrolled(retrospective-prospective), open-label,active-treatment study to evaluate the efficacy, safety,tolerability and pharmacokinetics of cinacalcethydrochloride for the treatment of secondaryhyperparathyroidism in paediatric subjects with chronickidney disease on dialysis, followed by 12-month studyextension. - Cinacalcet in paediatric secondary HPT due to CKD

• Conditions: secondaryhyperparathyroidism in paediatric subjects with chronickidney disease; MedDRA version: 9.1Level: LLTClassification code 10020708

• Registration Number: EUCTR2009-016797-32-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be eligible for inclusion into this study, the subjects must fulfill all of the following
criteria at study entry:
- Parents/guardian written informed consent, and childs assent given before any studyrelated
procedure not part of the subjects normal medical care, with the understanding
that consent may be withdrawn by the subject at any time without prejudice to his or her
future medical care.
- Age > 2 and <18 years;
- A dry body weight (BW) >10.49 Kg in males and >9.95 Kg in females, respectively;
- Inpatient or outpatient status at the time of enrolment;
- Males or females. Female subjects sexually active must be neither pregnant nor breastfeeding,
and must lack childbearing potential from screening visit to the end of the
safety follow-up, as defined by using an effective form of contraception (i.e. condoms,
oral contraceptives or intra-uterine device-IUD). Medically approved contraception
could include abstinence. Oral contraception will be accompanied by a barrier method.
A negative serum pregnancy test is required prior to initiation of treatment with study
medication.
- On stable hemodialysis (HD) or peritoneal dialysis (PD) for their CKD for at least one
month before entering the 6-month pre-treatment period;
- Plasma iPTH levels > 300 pg/mL, AND
- Plasma calcium (Ca) levels > 9.4 mg/dL (with normal serum albumin level), AND
- Plasma phosphorus (P) levels <6.5 mg/dL in patients younger than 6 years, or <6.0
mg/dL in older patients, OR
- Ca x P product > 60;
- Records availability for the following parameters 6 months prior to study entry:
demographic information, physical examination, height and dry weight,
auxological/anthropometric indices, blood pressure values, Kt/V urea, plasma iPTH,
calcium, phosphorus, and alkaline phosphatase levels, blood pH and bicarbonate,
serum creatinine/urea, C reactive protein (CRP) levels, liver function tests, blood
count, blood 25(OH) vitamin D3 level.
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for inclusion in this study the subjects must not meet any of the following
criteria at study entry:
- The following laboratory values: Hb<9.0 g/dL, WBC<2000/mm3 (2x109/L), platelets
<150,000/mm3 (150x109/L) only in subjects who are otherwise eligible for PK/PD
assessments; abnormal liver function, defined by a total bilirubin ≥2 times the upper
limit of normal values, aspartate aminotransferase, alanine aminotransferase or γ
glutamyltranspeptidase (γ-GT) levels ≥2 times the upper limit of normal values.
- Any other lab values that in the opinion of the investigator might place the subject at
unacceptable risk for participation in the study.
- History of malignancy (active malignancy, or off therapy since less than 1 year)
- History of diseases causing hypercalcemia (primary hyperparathyroidism; parathyroid
carcinoma; Williams syndrome; prolonged immobilization)
- Chronic inflammatory diseases (C-Reactive Protein-CRP >2 times the upper limit of
normal values) requiring a concomitant corticosteroid or immunosuppressive therapy
- History of infectious diseases (including opportunistic infections) within 4 weeks
prior to study entry
- Evidence as assessed by the Investigator of active or latent bacterial, viral or fungal
infections at the time of potential enrollment, including subjects with evidence of
Human Immunodeficiency virus (HIV) infection.
- Hepatitis-B surface antigen-positive subjects only in subjects who are otherwise
eligible for PK/PD assessments
- Hepatits C antibody-positive subjects who are also PCR-positive or RIBA positive
only in subjects who are otherwise eligible for PK/PD assessments
- Use of recombinant human growth hormone therapy
- Use of tricyclic antidepressant use
- Use of drugs that interact with cinacalcet disposition, such as ketoconazole,
itraconazole, telythromycin, voryconazole, ritonavir, rifampin
- Previous use of cinacalcet
- History of hypersensitivity to any of the ingredients of the study drug.
- Use of any investigational drug, device or biologic within 4 weeks prior to study entry
or during the study.

Study & Design

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