The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp
Recruiting · NCT04330729 · Interventional (participants receive a specific treatment) · Lead sponsor: Zealand University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The aim of the study is to 1. To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how. 2. To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
- aged 18-85
- indication for treatment with Erythropoiesis-stimulating agents (ESA)
Exclusion criteria
- Known allergy to ASA
- Known contraindication to ASA, e.g. recent bleeding episode.
- Known indication for ASA. If the patient is being treated with ASA, and the physician does not find any indication for this treatment, this can be stopped, and the patient included after 4 weeks.
- Raised reticulocyte count
- Current anticoagulant therapy, e.g. warfarin, ADP receptor inhibitor (excepting short-term anticoagulant therapy in connection with dialysis)
- Short expected length of life
- Inability to give informed consent
- Expected non-compliance
- Active cancer - except for non-melanoma skin-cancer
- Iron deficiency (defined as a reticulocyte Hgb \<1,8 fmol. Patients can be included when their iron deficiency has been cured. .
- Change in ESA dosis \>33,3% within previous 2 month
- Fertile women. Pregnancy is excessively rare in dialysis patients. Women who are \<50 years, or who are still menstruating will be excluded from the study.
- Stable Aranesp ® dose \<20 µg/week.
Where it is running
1 location listed.
- Medicinsk afdeling, SUH Roskilde - Roskilde, Denmark