E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Kidney Failure (requiring dialysis). |
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E.1.1.1 | Medical condition in easily understood language |
Renal failure, also known as kidney failure or renal insufficiency, is a medical condition in which the kidneys fail to adequately filter waste products from the blood. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023420 |
E.1.2 | Term | Kidney failure chronic |
E.1.2 | System Organ Class | 100000070575 |
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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 determine the effectiveness of cholecalciferol (inactive vitamin D) taken at a dose of 60,000 International Units (IU) fortnightly in improving survival of patients with kidney disease who require dialysis. |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of cholecalciferol (inactive vitamin D) taken at a dose of 60,000 International Units (IU) fortnightly on quality of life and secondary clinical outcomes in patients with kidney disease who require dialysis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have given written informed consent to participate • Age 18 years or over • UK Resident • Have dialysis-requiring End Stage Renal Disease
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E.4 | Principal exclusion criteria |
• Current treatment with high dose (>1,000IU/day) cholecalciferol • Women who are pregnant / planning to become pregnant or are breastfeeding • Persistent hypercalcaemia (>2.62 mmol/l on three separate occasions without precipitating cause • Life expectancy < 6 months • Not contributing, or willing to contribute, data to the UK Renal Registry • Inability to provide informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
All-cause mortality (death). SIMPLIFIED is powered to detect a 13% reduction in all-cause mortality. Data will be obtained via the Office of National Statistics. Assessment of the primary endpoint will require 2200 events. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The endpoint will be evaluated once 2200 events are confirmed. |
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E.5.2 | Secondary end point(s) |
• Health Related Quality of Life (via questionnaire) • Cardiovascular events • Admission requiring infections • Cancer • Admission requiring fractures |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The endpoint will be evaluated once 2200 events are confirmed for the primary outcome measure. |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control arm = standard of care |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 65 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 end of trial will be defined when the data for 2,200 events has been confirmed. |
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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 | 8 |
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 | 8 |
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 |