E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperphosphataemia in haemodialysis subjects |
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MedDRA Classification |
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 |
A comparison of the efficacy of Alpharen™ in the control of serum phosphate concentrations compared with placebo. |
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E.2.2 | Secondary objectives of the trial |
·To determine the mean serum phosphate, calcium, calcium-phosphate product, parathyroid hormone and magnesium concentrations during treatment in the double-blind comparative phases; ·To determine the safety of Alpharen™ compared with placebo.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female subjects on active haemodialysis, aged 18 years or over; 2. Written informed consent given; 3. On a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period; 4. On a stable dose of a phosphate binder for at least 1 month prior to screening; 5. Willing to abstain from taking any phosphate binder or oral magnesium or aluminium -containing products and preparations, other than the study medication; 6. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating; 7. Willing to maintain their usual type and dose of Vitamin D supplementation. |
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E.4 | Principal exclusion criteria |
1. Participation in any other clinical trial using an investigational product or device within the previous 4 months; 2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator; 3. Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; 4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator. 5. Any malignancy with the exception of basal cell carcinoma; 6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction; 7. A significant illness in the 4 weeks before screening; 8. Taking medication for seizures; 9. A history of haemochromatosis; 10. A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation); 11. A history of dysphagia or swallowing disorders; 12. Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device; 13. Current haemoglobin concentration of < 10.00 g/dL; 14. Allergy to the IMP or its constituents. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy analysis is the proportion of subjects in the Primary Per Protocol analysis population who have achieved controlled serum phosphate concentrations during the double-blind comparative phase. A subject will have achieved controlled serum phosphate concentrations if the mean serum phosphate concentrations during the double-blind comparative phase is ≥ 1.13 mmol/L and < 1.78 mmol/L. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 the trial is defined as 15 days after the Last Subject Last Visit (i.e., the end of the SAE reporting period). |
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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 | 6 |
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 | 6 |