E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hyperphosphataemia in patients with chronic kidney disease (CKD) on haemodialysis |
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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 |
To evaluate long term safety data in patients who have completed a clinical study on SBR759
(ie: to provide long term safety and efficacy data on patients who have been titrated to achieve phosphate target within Phase II/III studies of SBR759 and completed these studies on SBR759. In addition, the study will provide access to continued SBR759 maintenance therapy for these patients. The study is an open-label, non-randomized design where patients will continue on their currently assigned dose from the previous SBR759 study) |
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E.2.2 | Secondary objectives of the trial |
To evaluate sustained efficacy in patients who have completed a clinical study on SBR759. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who have completed a dose-titration study on treatment with SBR759. |
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E.4 | Principal exclusion criteria |
History of hypersensitivity to any of the study drug. History of malignancy of any organ system ( other than localized basal cell carcinoma of theskin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis. Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are Women whose career, lifestyle, or sexual orientation precludes intercourse with male partner Women whose partners have been sterilized by vasectomy or other means Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectibles, combined oral contraceptives, and some intrauterine devices (IUDs), Periodic abstinence(e.g. calendar, ovulation, symptothermal, post ovulation methods are not acceptable. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate long term safety data in patients who have completed a clinical study on SBR759. |
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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 | 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) | Yes |
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 | 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) | 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 | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
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
|
Data analysis will be carried out twice; an interim analysis after the study has been running for two years and a final analysis at the end of the study. The interim analysis will provide for a pre-specified safety and efficacy assessment when the first patients have had approximately three years total exposure to SBR759, including the prior study. This interim approach is designed to be independent of the study duration and of the prior studies from which patients may enter this 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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |