E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyroidism in subjects with chronic kidney disease |
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E.1.1.1 | Medical condition in easily understood language |
Hyperparathyroidism (high levels of parathyroid hormone) secondary to
chronic kidney disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020708 |
E.1.2 | Term | Hyperparathyroidism secondary |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020706 |
E.1.2 | Term | Hyperparathyroidism NOS |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis. |
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E.2.2 | Secondary objectives of the trial |
To characterize intact parathyroid hormone (iPTH), total serum corrected calcium (cCa), and serum phosphorous (P) values in the treatment of SHPT in subjects with CKD on hemodialysis, who are being treated with AMG 416. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
101. Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
102. Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01).
103. Female subjects who are:
• post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years)
• surgically sterilized
• have a medical condition that prevents pregnancy
• remain abstinent
• or are willing to use highly effective contraception during the study and for 3 months after the last dose
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study.
104. Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months.
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E.4 | Principal exclusion criteria |
201. Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies).
202. Other investigational procedures while participating in this study are excluded.
203. Subject has known sensitivity to any of the products or components to be administered during dosing.
204. Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study.
205. Subject has any illness that, in the judgment of the Investigator, might confound the results of the study or pose additional risk to the subject.
206. Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
207. Subject is pregnant or nursing.
208. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the judgment of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of adverse events reported throughout the study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Occurrence of iPTH value at Months 6, 12, and 18 which is within 2x to 9x the upper limit of normal (ULN) for the assay used
• Occurrence of P ≤ the ULN for the assay used at Months 6, 12, and 18
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 95 |
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 | No |
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 |
Austria |
Belgium |
Czech Republic |
Denmark |
Estonia |
France |
Germany |
Greece |
Hungary |
Israel |
Italy |
Latvia |
Lithuania |
Mexico |
Netherlands |
Poland |
Portugal |
Russian Federation |
Spain |
Sweden |
Switzerland |
Turkey |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |