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 hemodialysis |
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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 | 10020712 |
E.1.2 | Term | Hyperphosphatemia |
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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 |
This study is designed to demonstrate superior or at least non-inferior efficacy of SBR759 in phoshate binding, versus sevelamer HCl and evaluate safety over a long term exposure. Efficacy will be measured by the number of patients with a serum phosphate level below or equal to 5.5 mg/dl (i.e. 1.78 mmol/L) at 12 weeks |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety and tolerability of SBR759 compared to sevelamer HCl over a 12-week period. To evaluate whether SBR759 has superior efficacy at week 12 compared to sevelamer HCl, as measured by the number of patients with a serum calcium-phosphate product levels below or equal to 55 mg2/dL2. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Assessments subjects to an additional informed consent form but included in the main protocol: - phosphate dynamics during dialysis (evaluation of phosphate levels removed during dialysis in all patients and validation of Gutzwiller formula in 12 patients) - Imaging and Pulse Wave Velocity procedure (evaluation of changes in bone metabolism and vascular calcification in 50 patients) |
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E.3 | Principal inclusion criteria |
- Men or women of at least 18 years old. - Patient must be treated with a stable maintenance hemodialysis - Patient must be on restricted phosphate diet at screening and throughout the study. - Patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and < 6.0 mg/dL (< 1.9 mmol/L) - Patient has a serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation. - Patient must have a Urea Reduction Ratio of > 65% (obtained within 2 weeks prior to screening) - If patient has a history of parathyroidectomy, iPTH and calcium-phosphate product levels should be stable within 30 days prior to screening. - Patient must be on a stable phosphate binder dose. |
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E.4 | Principal exclusion criteria |
Patient is on peritoneal dialysis or a non-conventional hemodialysis technique (e.g. hemofiltration, hemodiafiltration) Patient has a parathyroidectomy or transplant scheduled during the study. Patient has an uncontrolled hyperparathyroidism Patient has a history of hemochromatosis or ferritin > 800 μg/L. Patient has a clinically significant GI disorder Patient has a chronic unstable GI disorder Patient has an history of major gastrointestinal tract surgery Patient is / has been treated with sevelamer HCl monotherapy or SBR759 within 3 months prior to screening. History of intolerance to sevelamer HCl. Patient is currently being treated with oral iron. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with a serum phosphate level below or equal to 5.5 mg/dL (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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
change in bone metabolism and vascular calcification biomarkers; dynamics of phosphate levels in HD |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
Stratified per serum phosphorus levels (<or>= to 75.mg/dL) |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | Yes |
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 trial will be considered completed after completion of the extension study, including the 2 weeks random treatment withdrawal 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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |