Status:
RECRUITING
The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp
Lead Sponsor:
Zealand University Hospital
Conditions:
Erythropoietin Adverse Reaction
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 tr...
Detailed Description
Background: It is well known that treatment with EPO increases the risk of thrombotic complications in patients with chronic kidney disease, including cerebral thrombosis. The requited level of Hgb f...
Eligibility Criteria
Inclusion
- Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
- aged 18-85
- indication for treatment with Erythropoiesis-stimulating agents (ESA)
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04330729
Start Date
April 15 2020
End Date
December 31 2026
Last Update
January 25 2024
Active Locations (1)
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1
Medicinsk afdeling, SUH Roskilde
Roskilde, Denmark, 4000