E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperphosphataemia in haemodialysis subjects |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020711 |
E.1.2 | Term | Hyperphosphataemia |
|
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 tolerability of up to five doses (1.0-3.0 g) of Alpharen™. |
|
E.2.2 | Secondary objectives of the trial |
A comparison of the effect of Alpharen™ and sevelamer on arrhythmogenic potential (including QTc interval). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures; 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-, aluminium- or iron-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. On a dialysate magnesium ion concentration of ≤ 1.0 mmol/L for at least 1 month prior to screening. |
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E.4 | Principal exclusion criteria |
1. Received a cardiac transplant; 2. Heart failure according to New York Heart Association (NYHA) Functional IV Classification; 3. Participation in any other clinical trial using an investigational product or device within the previous 4 weeks; 4. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator; 5. 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opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; 6. Clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator; 7. Any history of recent clinically significant malignancy; 8. A significant illness (excluding renal disease) in the 4 weeks before screening; 9. A history of poorly controlled epilepsy; 10. 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; 11. Allergy to Alpharen™ or sevelamer or any component of the formulations |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of intolerance is defined as any of the following: 1. Change in bowel habit intolerable to the subject. 2. Severe nausea. 3. Severe dyspepsia. 4. Severe abdominal pain. 5. Persistent (>2 episodes per day) vomiting. 6. Diarrhoea (liquid stool according to the Rome II classification). 7. Serum magnesium > 2.0 mmol/L. 8. Serum phosphate < 0.7 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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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 | 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) | Yes |
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
| Information not present in EudraCT |
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 | 6 |
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 | 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
|
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |