E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009122 |
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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 |
- Evaluate the efficacy of sevelamer carbonate tablets dosed three times a day (TID) with meals on control of serum phosphorus levels
- Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals |
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E.2.2 | Secondary objectives of the trial |
To evaluate sevelamer carbonate tablets dosed TID with meals on the following: - serum calcium-phosphorus product - serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein(LDL) cholesterol] - percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.86 and 1.47 mmol/L), inclusive] at Day 56/early termination
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women 18 years of age or older 2. If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period 3. Willing to avoid any intentional changes in diet such as fasting or dieting 4. Have the following central laboratory measurement: a) If not taking a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit 1). b) If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0). 5. At Screening (Visit 1), have the following central laboratory measurements: a) 25-hydroxyvitamin D >10 ng/mL. b) iPTH ≤ 800 pg/mL 6. Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study 7. Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons 8. Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement 9. If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs 10. Expecting not to initiate dialysis for the duration of this study 11. Considered compliant with phosphate binders (if applicable) 12. Willing and able to provide informed consent 13. Has not participated in any other investigational drug studies within 30 days prior to enrollment 14. 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. Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders 2. Active ethanol or drug abuse, excluding tobacco use 3. Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders. 4. In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition 5. Pregnant or breast-feeding 6. Evidence of active malignancy except for basal cell carcinoma of the skin 7. Unable to comply with the requirements of the study 8. Known hypersensitivity to sevelamer or any constituents of the study drug 9. Any other condition, which in the opinion of the investigator will prohibit the patient’s inclusion in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to Day 56/early termination in serum phosphorus |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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.8.3 |
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 | 18 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |