E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of secondary hyperparathyroidism (SHPT) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020708 |
E.1.2 | Term | Hyperparathyroidism secondary |
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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 evaluate the ability of a treatment strategy that includes the use of cinacalcet in combination with low dose active vitamin D sterols (if prescribed) to control parathyroid hormone (PTH) compared with flexible active vitamin D sterols (flexible vitamin D) dosing (if prescribed) per standard treatment guidelines over a 6-month period in subjects recently initiating hemodialysis (within 3 to 12 months of enrollment) with SHPT and CKD |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of the treatment strategy on achieving and maintaining treatment targets for PTH, calcium (Ca), and phosphorus (P) To determine the safety and tolerability of cinacalcet in a population of subjects recently initiating dialysis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects will be eligible for the study if they meet all of the following criteria: Adults ≥ 18 years of age on hemodialysis for > 3 and ≤ 12 months prior to enrollment into the study Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L) Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations ≥ 8.4 mg/dL (2.1 mmol/L) Subject will be able to complete the study, to the best of his/her knowledge Before any study-specific procedure, the appropriate written informed consent must be obtained |
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E.4 | Principal exclusion criteria |
Subjects will be ineligible for the study if they fulfill any of the following criteria: Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening Parathyroidectomy (partial or full) ≤ 6 months before entering screening Anticipated parathyroidectomy (partial or full) within 6 months after randomization Have a scheduled date for kidney transplant surgery Received cinacalcet since initiating hemodialysis Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening Subject is pregnant (eg, positive HCG test) or is breast-feeding Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment) Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of a ≥ 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Vitamin D (standard of care) |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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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The end of study (EOS) is defined as the date that the subject completes the week 56 visit, or the date that a subject completes his/her last study procedure/assessment if the subject is prematurly terminated from the study. |
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |