E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type 1 and diabetic nephropathy |
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E.1.1.1 | Medical condition in easily understood language |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012638 |
E.1.2 | Term | Diabetes with renal manifestations |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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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 |
Evaluation of the impact of three months treatment with capsule Zemplar® (paricalcitol) versus placebo on the primary endpoint: Plasma NT-proBNP in patients with type 1 diabetic nephropathy and chronic kidney disease (eGFR 15-70ml/min) |
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E.2.2 | Secondary objectives of the trial |
Evaluation of the intervention on other biomarkers for: • Vascular calcification and arterial stiffness • Inflammation • endothelial dysfunction • Urinary Albumin Excretion Rate (UAER)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18-75 years of age 2. Type 1 diabetes mellitus (WHO criteria) 3. Diabetic nephropathy 4. Chronic kidney disease (eGFR/GFR 15-70ml/min/1.73m2) 5. Parathyroid hormone analysis, s-iPTH> 35pg/ml (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive) 6. Stabile RAAS-blocking and diuretic treatment |
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E.4 | Principal exclusion criteria |
1.Diagnosed with other kidney disease than diabetic nephropathy 2. Myocardial infarction within the last three months prior to visit 1 3. Coronary artery revascularization within the last three months prior to visit 1 4. Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1 5. Cardiac Failure (NYHA Class III or IV) 6. Kidney Failure (GFR <15ml/min), dialysis, kidney transplantation 7. Liver disease with serum alanine aminotransferase (ALT) increased to more than three times the normal value (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive) 8. Alcohol/drug abuse 9. Hypercalcemia defined as serum ionized calcium >1.35 mmol /L (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive) 10 Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study 11. Clinical signs of vitamin D toxicity 12 Pregnant or nursing women 13 Fertile women not using chemical (contraceptive pills, depot injection of depot gestagen, contraceptive implant, vaginal hormonal ring, birth control patch) or mechanical (IUD) contraceptive methods 14 Current disulfiram treatment 15 Allergy to the study drug 16 Patient unable to understand the informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in change in plasma NT-proBNP when treated with capsule Zemplar® and capsule placebo |
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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 | Yes |
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) | 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 | 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 | Yes |
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.8.5 | 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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End of trial 01 May 2012 (last patient, last visit) |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |