E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vascular calcification, phosphate binders and patients on hemodialysis |
Vasculaire calcificatie, fosfaatbinders en patienten die hemodialyse ondergaan |
|
E.1.1.1 | Medical condition in easily understood language |
Vascular calcification |
Vasculaire calcificatie |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 |
This research will have as aim to look at progression or decrease of vascular calcification in dialysis population with use of different phosphate binders. There is a possibility that differect phosphate binders bind vitamin K in a different way in intestinal tract end thereby cause different level of calcification.
Level of calcification will be measured by dp-ucMGP which is used as markers for vascular calcification. Because of the fact that ucMGP en dp-ucMGP are vitamin K dependant PIVKA-II will be measured as well.
Better insight in mechanisms of vascular calcification under different circumstance can lead to therapeutic options which inhibit calcification and benefit survival of dialysis patients |
Het onderzoek gaat zich richten op de calcificatie en de progressie of vermindering ervan bij de dialyse populatie onder het gebruik van verschillende fosfaat binders. Mogelijk dat de verschillende fosfaatbinders in de tractus digestivus verschillend vitamine K binden en daardoor ook een verschil in calcificatie optreed.
De mate van calcificatie wordt bepaald door dp-ucMGP bepalingen, die als marker voor vaatcalcificatie gebruikt worden. Aangezien de dp-ucMGP vitamine K afhankelijk is zal tevens PIVKA-II bepaald worden.
Beter inzicht in mechanismen van calcificatie onder verschillende omstandigheden kan leiden tot therapie-aanpassingen die calcificatie remmen en de overlevingsduur van de dialyse patienten kunnen bevorderen. |
|
E.2.2 | Secondary objectives of the trial |
Difference in vascular calcification with vitamin K suppletion |
Verschil in vasculaire calcificatie met vitamine K suppletie |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Dialysis patients older than 18 years without the prospect of renal function recovery and life expectancy longer than six months. |
Hemodialyse patiënt ouder dan 18 jaar waarbij geen vooruitzicht is op een spontaan herstel van de nierfunctie en met een levensverwachting van minimaal 6 maanden
|
|
E.4 | Principal exclusion criteria |
1 Use of vitamin K antagonists
2 Calcium under 2,1 or above 2,6 mmol/l
3 Pregnancy
4 Phosphate under 1,4 or above 2,2 mmol/l
5 Allergy or intolerance for study medication
6 PTH under 15 or above 65 pmol/l |
1 Gebruik van vitamine K afhankelijke antistolling tijdens het onderzoek.
2 Gecorrigeerd calcium kleiner dan 2,1 of groter dan 2,6 mmol/l
3 Zwangerschap.
4 Fosfaat waarde kleiner dan 1,4 of groter dan 2,2 mmol/l
5 Allergie of intolerantie voor de studie medicatie
6 PTH kleiner dan 15 of groter dan 65 pmol/l |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference in dp-ucMGP en PIVKA II level after eight weeks of treatment with lanthanumcarbonate or calciumcarbonate. |
Verschil in de hoogte van dp-ucMGP enPIVKA-II na acht weken behandeling met lanthanumcarbonaat of calciumcarbonaat. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
8 and 16 weeks |
8 en 16 weken |
|
E.5.2 | Secondary end point(s) |
Association between change of dp-ucMGP and PIVKA-II level after menaquinon suppletion. |
Verandering in de hoogte van dp-ucMGP en PIVKA-II na suppletie van menaquinon. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
16 and 20 weeks |
16 en 20 weken |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
interactions of phosphatre binders with vitamin K |
interactie tussen de verschillende fosfaatbinders en vitamine K |
|
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| 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 | No |
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
|
End of trial is after all patientes have been includede and have had their last visit. |
Einde van het onderzoek zal zijn als alle patienten geincludeerd zijn en de laatste controle hebben volbracht. |
|
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 | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |