EUCTR2009-016797-32-IT进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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- •that consent may be withdrawn by the subject at any time without prejudice to his or her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
排除标准
- •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.
研究者
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