E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
serum phosphate levels in Chronic Kidney Disease patients 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 | 10020711 |
E.1.2 | Term | Hyperphosphataemia |
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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 |
To demonstrate superior efficacy or at least non-inferiority of SBR759 compared to sevelamer HCl, as 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. To evaluate whether SBR759 is associated with less increase in serum iPTH levels compared to sevelamer HCl at 12 weeks. To evaluate whether SBR759 has an equivalent rate of hypercalcemia events at 12 weeks compared to sevelamer HCl as measured by serum calcium levels. To evaluate changes in patient-reported gastrointestinal symptom burden, using gastrointestinal symptom rating scale (GSRS) total and subscales scores, in patients treated with SBR759 compared to patients treated with sevelamer HCl. PLS SEE PROTOCOL |
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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 |
ALTRI SOTTOSTUDI: sottostudio per la valutazione della dinamica dei fosfati
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E.3 | Principal inclusion criteria |
Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patients must give written informed consent before any assessment is performed. 2. Men or women of at least 18 years old. 3. Patient must be treated with a stable maintenance hemodialysis (i.e. no change in dialysis material and parameters) 3 times per week for > 3 months before screening and planned to be maintained the same throughout the study duration. 4. Patient must be on restricted phosphate diet at screening and throughout the study. 5. Patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and < 6.0 mg/dL (< 1.9 mmol/L), as indicated by the average of the 2 latest pre-dialysis laboratory values reported prior to screening, if currently under phosphate binder therapy. 6. Patient has a serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L), obtained from central laboratory, prior to study treatment initiation. 7. Patient must have a Urea Reduction Ratio of > 65% (obtained within 2 weeks prior to screening). 8. If patient has a history of parathyroidectomy, iPTH and calcium-phosphate product levels should be stable within 30 days prior to screening. 9. Patient must be on a stable phosphate binder dose (i.e. No change in prescribed dose) for at least 30 days prior to screening, or is newly diagnosed with hyperphosphatemia and has not initiated treatment with phosphate binder yet. 10. Patient must, in the investigators opinion, be compliant with prescribed phosphate binders. 11. If patient is currently being treated with calcimimetics, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration. 12. If patient is currently being treated with vitamin D, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration. 13. If patient is currently being treated with IV iron, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration. 14. If patient is currently being treated for osteoporosis, the prescribed dose must be constant for at least 30 days prior to screening and during the total core study duration. |
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E.4 | Principal exclusion criteria |
1. Patient is on peritoneal dialysis or a non-conventional hemodialysis technique (e.g. hemofiltration, hemodiafiltration) 2. Patient has a parathyroidectomy or transplant scheduled during the study. 3. Patient has an uncontrolled hyperparathyroidism (i.e. intact PTH > 800 pg/mL within 30 days prior to study screening) 4. Patient has a history of hemochromatosis or ferritin > 800 μg/L. 5. Patient has a clinically significant GI disorder (i.e. swallowing disorder, active dysphagia, bowel obstruction, severe GI motility disorder) 6. Patient has a chronic unstable GI disorder (e.g. Irritable Bowel Syndrome, Inflammatory Bowel Disease, chronic abdominal pain, chronic diarrhea) |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate superior efficacy or at least non-inferiority of SBR759 compared to sevelamer HCl, as 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.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 | 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) | 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
| 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 | 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |