E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elevated serum phosphate levels (hyperphosphataemia) in patients with chronic renal failure on dialysis (haemodialysis, peritoneal dialysis) |
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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 |
The primary objective of the present study is to show the non-inferiority regarding phosphate binding in the OsvaRen® Group compared to the Renagel® Group. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of either sex aged 18-85 years. 2. Patients stable on 3x/week haemodialysis or online haemodiafiltration for at least three months, and who will continue to receive 4-6 hours haemodialysis 3x/week. 3. Patients willing to maintain an unchanged diet and dialysis regimen during washout/run-in and treatment phases of the study. 4. Patients requiring oral therapy with a phosphate binder. 5. Patients whose serum phosphorus is ≥ 1.78 mmol/L (5.5 mg/dL) after washout of phosphate binder 6. Patients who are either on a stable dose of vitamin D and/or of calcimimetics for at least one month or do not require vitamin D therapy or calcimimetics. 7. Patients whose single pool Kt/V is > 1.4 or whose double pool Kt/V is > 1.2 according last measurement before Screening. 8. Patients who agree to discontinue the consumption of any other calcium or magnesium supplement or antacid containing Al, Mg or Ca during study participation. 9. Patients who have a life expectancy not shorter than the duration of the study. 10. Patients willing to comply with the study protocol. 11. Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).
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E.4 | Principal exclusion criteria |
1. Patients with known hypersensitivity to any component of the trial drugs. 2. Patients with intact parathyroid hormone (iPTH) level < 100 or > 800 pg/ml according to last routine measurement before Screening. 3. Patients whose serum magnesium is > 1.5 mmol/L at the end of the washout/run-in period. 4. Patients whose serum calcium is > ULN at the end of the washout/run-in period. 5. Patients with heart failure NYHA class 3-4. 6. Patients with catheter access. 7. Patients with known acute or chronic infections. 8. Patients with malignant hypertension. 9. Patients with acute gastrointestinal bleeding. 10. Patients with active malignancies. 11. Patients with myasthenia gravis. 12. Patients with active inflammatory bowel disease or ileus. 13. Patients with uncontrolled, clinically significant AV block grade III, AV block grade II with bradycardia or with brady-arrhythmias. 14. Patients with current or past alcohol or drug abuse within the last 2 years before screening. 15. Patients participating in a clinical trial within the last 30 days before Day 1. 16. Any serious medical condition, which would hinder the patient’s ability to fully comply with the protocol. 17. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Serum phosphorus at Week 25 |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 |
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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 | Yes |
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 | 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
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last visit of last subject |
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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 |