E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperphosphataemia in patients with Chronic Kidney Disease Stage 5 receiving 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 assess the percentage of subjects who have serum phosphorous levels controlled to < or = 1.78mmol/L (< or = 5.5mg/dl) followining treatment with Fosrenol compared to their previous phosphae binder therapy. |
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E.2.2 | Secondary objectives of the trial |
To assess the following:
If Fosrenol can maintain serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy.
If Fosrenol can reduce serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy.
To assess the control of serum calcium phosphorus product
To assess the average dose of Fosrenol
To assess the safety and tolerability of Fosrenol
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria is as follows:
1. Male or female subjects > 18 years of age. Females of child beraing potential must be non-pregnant, non lactating, have a negative serum HCG pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol. 3. Must be receiving a stable regimen of haemodialysis for CKD stage 5(defined as haemodialysis three times per week for at least 2 months prior to screening). 4. Must be on a stbale calcium based phosphate binder and/or sevelamer HCL dose (defined as no change in medication or dosage for one month) with a serum phosphorous level >1.78 and <2.43mmol/L (>5.5 and <7.5mg/dl). 5. Must understand and be able, willing and likely to fully comply with study procedures and restrictions. 6. Written, signed and dated informed consent to participate in the study must be given by the subject or legally acceptable representative, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practise (GCP) Guideline E69 and applicable regulations before completing any study related procedures listed in the protocol
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E.4 | Principal exclusion criteria |
The exclusion criteria is as follows:
1. A corrected serum calcium level <2.2mmol/L (<8.8mg/dL). 2. An intact parathyroid hormone level >500pg/mL. 3. A history of previous parathyroidectomy within the past 12 months. 4. A life-threatening malignancy or current multiple myeloma, or known to be Human Immunodeficiency Virus (HIV) positive. 5. Any significant bowel obstruction, active inflammatory bowel disease, GI motililty disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months. 6. A clinically significant uncontrolled concurrent illness, which in the opinion of the Investigator would impair their ability to give informed consent or take part in or complete the study. 7. The subject is receiving greater than 3000mg/day elemental calcium (7500mg/day calcium carbonate) as a phosphate binder. 8. The subject is receiving greater than 9600mg/day sevelamer HCL. 9. The subject is receiving aluminium, magnesium, or combination therapy other than calcium and sevelamer HCL as a phosphate binder. 10. The subject requires treatment with cinacalcet HCL. 11. A known or suspected intolerence or hypersensitivity to the study drug or any of the stated ingredients. 12. A history of alcohol or other substance abuse within 6 months prior to screening. 13. The subject has used any Investigational Product or has taken part in a clinical trial within the last 30 days prior to screening. 14. The subject has previously been enrolled in this study and subsquentely withdrawn
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects achieving serum phosphorus levels of less that or equal to 1.78mmol/L following treatment with Fosrenol at week 12 compared to treatment with their previous phospahe binder therapy. |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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) | No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
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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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 | 17 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 17 |