NCT04330729 The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp
| NCT ID | NCT04330729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Erythropoietin Adverse Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2020-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 treatment changes the effect of EPO (erythropoietin) on platelet function.
Eligibility Criteria
Inclusion Criteria: * Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively * aged 18-85 * indication for treatment with Erythropoiesis-stimulating agents (ESA) Exclusion Criteria: 1. Known allergy to ASA 2. Known contraindication to ASA, e.g. recent bleeding episode. 3. 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. 4. Raised reticulocyte count 5. Current anticoagulant therapy, e.g. warfarin, ADP receptor inhibitor (excepting short-term anticoagulant therapy in connection with dialysis) 6. Short expected length of life 7. Inability to give informed consent 8. Expected non-compliance 9. Active cancer - except for non-melanoma skin-cancer 10. Iron deficiency (defined as a reticulocyte Hgb \<1,8 fmol. Patients can be included when their iron deficiency has been cured. . 11. Change in ESA dosis \>33,3% within previous 2 month 12. 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. 13. Stable Aranesp ® dose \<20 µg/week.
Contact & Investigator
James G Heaf
STUDY DIRECTOR
Department of medicine, Zealand University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT04330729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Erythropoietin Adverse Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04330729 currently recruiting?
Yes, NCT04330729 is actively recruiting participants. Contact the research team at mkof@regionsjaelland.dk for enrollment information.
Where is the NCT04330729 trial being conducted?
This trial is being conducted at Roskilde, Denmark.
Who is sponsoring the NCT04330729 clinical trial?
NCT04330729 is sponsored by Zealand University Hospital. The principal investigator is James G Heaf at Department of medicine, Zealand University Hospital, Denmark. The trial plans to enroll 60 participants.