E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic kidney disease and vitamin D deficiency. |
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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 | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
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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 | 10064848 |
E.1.2 | Term | Chronic kidney disease |
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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 |
Primary study objective – to evaluate the effects of vitamin D on the microcirculation of patients with chronic kidney disease (CKD) and vitamin D deficiency. |
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E.2.2 | Secondary objectives of the trial |
Secondary study objective – to evaluate the effects of vitamin D on key clinical parameters in patients with chronic kidney disease (CKD) and vitamin D deficiency. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria 1. eGFR between 15 and 60 ml/min/1.73m2 2. Serum 25 (OH) vitamin D levels <70nmol/L 3. No evidence of diabetes mellitus (fasting blood sugar <7.1, not taking any diabetic medication) 4. Not receiving haemo or peritoneal dialysis 5. No dialysis therapy within the last 3 months 6. Age > 18 years and < 80 years 7. Patient agrees not use any medications (prescribed or over-the-counter including herbal remedies) judged to be clinically significant by the Principal Investigator during the course of the study. 8. Able to understand and sign the written Informed Consent Form. 9. Able and willing to follow the Protocol requirements.
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Currently receiving oral ergocalciferol at any dose 2. Received IM ergocalciferol therapy within last 3 months 3. Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months) 4. Pacemaker or any other implanted cardiac device 5. Serum calcium above 2.6 mmol/L at screening 6. Pregnant or lactating 7. Known hypersensitivity to ergocalciferol 8. Patient known to have a condition which predisposes to hypercalcaemia (multiple myeloma, sarcoidosis, other granulomatous disease) 9. Initial blood pressure of >160/100 mmHg 10. History of significant liver disease or cirrhosis 11. Anticipated requirement for dialysis in 6 months 12. Malabsorption, severe chronic diarrhea, or ileostomy 13. Known diagnosis of hypervitaminosis D 14. Known to have diabetes mellitus 15. Known to have renal calculi 16. Known to have systemic sclerosis, Raynaud’s phenomenon or other disease associated with known microcirculatory dysfunction 17. Concurrent participation in any other research study 18. Unwilling or unable to complete study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Study Endpoints
Microcirculatory studies – pulse wave velocity (PWV), iontophoresis of acetyl choline (AcH) and sodium nitroprusside (SNip), skin autofluoresence (AF) and side stream dark field imaging of the sub lingual microcirculation.
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 1 |
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 | 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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The study officially ends when the last patients has had the last dose of medication and undergone the last set of clinical assessments. Data analysis and publication may continue after this point. |
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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 | 2 |
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 | 2 |
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 |