The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp

Recruiting now · Not applicable

Conditions studied: Erythropoietin Adverse Reaction

In brief

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.

Key facts

Study ID

NCT04330729

Run by

Zealand University Hospital

People needed

60

Starts

2020-04-15

Expected to finish

2026-12-31

Last updated by the study team

2024-01-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
• aged 18-85
• indication for treatment with Erythropoiesis-stimulating agents (ESA)

You may not qualify if…

• 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

• Medicinsk afdeling, SUH Roskilde — Roskilde, Denmark (enrolling)

Full record on ClinicalTrials.gov

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