Vascular calcification due to phosphate binders in patients on hemodialysis

Phase 1

• Conditions: Vascular calcification, phosphate binders and patients on hemodialysis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003949-41-NL
• Lead Sponsor: VU medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Dialysis patients older than 18 years without the prospect of renal function recovery and life expectancy longer than six months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified