The effect of low-dose salicylate treatment on platelet function in patients with renal failure treated with darbopoietin alfa (EPOASA study)
Phase 1
- Conditions
- uraemiaMedDRA version: 20.0Level: LLTClassification code 10046321Term: Uraemia of renal originSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-002318-11-DK
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients with chronic kidney failure stage 5
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
Contraindication to Hjertemagnyl
Current beeding or increased bleeding risk
Current anticoagulant therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of darbopoietin alfa on platelet function<br>To determine whether hjertemagnyl affects the effect of darbopoietin alfa on platelet function;Secondary Objective: Not applicable;Primary end point(s): Evaluation at end of each therapeutic interval;Timepoint(s) of evaluation of this end point: 0-4-8-12-16 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: 4-8-12-16 weeks