E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim is to measure the effect of paricalcitol given orally in patients with moderate to severe chronic kidney diseases (CKD stage III-IV i.e. eGFR:15-59 ml/min) investigating vasoactive hormones, renal function, calcium metabolism, inflammatory markers, 24-hour ambulatory blood pressure, the nitric oxide system, central blood pressure, pulse wave velocity and augmentation index. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
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 |
Plasma renin concentration (PRC) |
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E.2.2 | Secondary objectives of the trial |
• Urinary albumin excretion • GFR, u-Na, u-K, CNa, CK, FENa ,FEK, CH2O, u-AQP2, u-ENaCβ , u-NCC • p-Aldo, p-Ang II, p-AVP, p-ANP, p-BNP, p-Endot • 24-hour ambulatory BP • Central BP, pulse wave velocity, augmentation index • p-Ca++, u-Ca, p-P, p-alkaline phosphatase, p-PTH, p-25-OH-vitamin D • p-hsCRP, p-TNFα and p-TGFß
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
L-NMMA’S EFFEKT PÅ NYREFYSIOLOGISKE OG KARDIOVASKULÆRE VARIABLE HOS RASKE FORSØGSPERSONER I ET RANDOMISERET, PLACEBO-KONTROLLERET, OVERKRYDSET DOSIS-RESPONS-STUDIUM Date: 2009-10-21 Version 1 This study is conducted as a preliminary dose-finding study investingating L-NMMA's effect on the nitric oxide system. |
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E.3 | Principal inclusion criteria |
• Age 18-65 years • Renal disease corresponding to CKD stage 3-4 (eGFR: 15-59 ml/min) • Both men and women • Albuminuria > 500 mg/l
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E.4 | Principal exclusion criteria |
• Medical history or clinical signs diseases in connective tissue, lungs, liver, endocrine organs • Former total parathyroidectomy • Diabetes • Malignant disease • Illicit drug use • Alcohol abuse (according to the recommendations from The Danish National Board of Health) • Pregnancy or nursing • Ongoing NSAID or corticosteroid treatment • Severe anemia (b-hemoglobin <6mmol/l) • Hypoalbuminemia (p-albumin <25 mmol/l) • Clinically significant hypercalcemia without calcium or vitamin D treatment. • Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement according to the department’s clinical guidelines.
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma renin concentration (PRC) |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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.8.4.1 | 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 | 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 trial ends after complete data analasis following the last visit of the 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 | 1 |
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 | 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 |