E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary hyperparathyroidism in Stage 3 or Stage 4 Chronic Kidney Disease |
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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 safety and tolerability of Hectorol Capsules during 52 weeks of treatment in patients with Stage 3 or Stage 4 CKD |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of Hectorol Capsules during 52 weeks of treatment in patients with Stage 3 or Stage 4 CKD |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, aged 18 years or older.
2. CKD Stage 3 or 4, defined as glomerular filtration rate (GFR) from the abbreviated Modification of Diet in Renal Disease (MDRD) equation between 30 and 59 mL/min/1.73m2 for CKD Stage 3 or between 15 and 29 mL/min/1.73m2 for CKD Stage 4 at the Screening Visit.
3. iPTH > 70 pg/mL (> 7.7 pmol/L) for CKD Stage 3 or > 110 pg/mL (> 12.1 pmol/L) for CKD Stage 4, but < 700 pg/mL (< 77 pmol/L) at Week –1.
4. In the opinion of the Investigator, the patient is willing and able to maintain compliance with phosphate binder therapy (if applicable) throughout the study duration.
5. Willing and able to stop any prior active vitamin D therapy (e.g. alfacalcidiol, calcitriol, or paricalcitol) and/or calcimimetic for 28 days prior to Week –1 and maintain this throughout the study.
6. Willing and able to sign and date an Informed Consent form.
7. The patient, if of childbearing potential, must be willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices.
8. A level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.
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E.4 | Principal exclusion criteria |
1. Intact PTH value > 700 pg/mL (> 77.0 pmol/L) at the Week -1 Visit.
2. Corrected serum calcium > 10.0 mg/dL (> 2.5 mmol/L) at Week –1.
3. Serum phosphorus > 5.0 mg/dL (> 1.61 mmol/L) at Week –1.
4. In the opinion of the Investigator, the patient currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any other clinically significant, unstable medical condition.
5. Abnormal liver function as measured by alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than three times the upper limit of normal at the Screening Visit.
6. Deemed by the Investigator to have rapidly deteriorating renal function.
7. Spot urine calcium/creatinine ratio > 0.2 at Week –1.
8. Current malabsorption, severe chronic diarrhea, or ileostomy.
9. Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion criterion.
10. Allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for hypersensitivity to vitamin D therapy.
11. Active ethanol or drug abuse, excluding tobacco use.
12. Current use of aluminum or magnesium based binders.
13. Pregnant or breast-feeding women.
14. Anticipated dialysis or planned renal transplant less than 12 months from Week 0.
15. Treatment with an investigational drug during 30 days preceding the start of screening.
16. Prior renal transplant.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety endpoints include the following: • Incidence of AEs and SAEs. • Changes in physical examination findings, vital signs, or laboratory evaluations.
The efficacy endpoint will be the proportion of patients meeting the iPTH target range (defined as iPTH ≤ 70 pg/mL (≤ 7.7 pmol/L) for Stage 3 patients and iPTH ≤ 110 pg/mL (≤ 12.1 pmol/L) for Stage 4 patients) at each timepoint during the Treatment Period. |
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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 | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |