Effect of Salicylate on Platelet Function in Chronic Kidney Disease Patients Treated with Aranesp
The Effect of Low-dose Salicylate Treatment on Platelet Function in Patients With Renal Failure Treated With Darbepoetin Alfa
This study is testing if the medication Aranesp affects how platelets work in people with chronic kidney disease and whether adding salicylate changes that effect.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Roskilde) |
| Trial ID | NCT04330729 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how treatment with Erythropoiesis-stimulating agents, specifically Aranesp, affects platelet function in patients with chronic kidney disease. It will also explore whether salicylate treatment alters the impact of erythropoietin on platelet function. The study involves a pre-treatment washout period followed by a treatment phase where patients receive Aranesp. Advanced methods for assessing platelet function will be utilized to gather data for future randomized controlled studies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with chronic kidney disease undergoing hemodialysis, peritoneal dialysis, or conservative treatment.
Not a fit: Patients with known allergies to acetylsalicylic acid or those currently on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce the risk of thrombotic complications in chronic kidney disease patients receiving erythropoietin treatment.
How similar studies have performed: Previous investigations have suggested potential benefits of low-dose acetylsalicylic acid in this context, but this study employs modern methods to reassess the hypothesis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roskilde
- Medicinsk afdeling, SUH Roskilde — Roskilde, Denmark (Recruiting)
Study contacts
- Study coordinator: Mette KOefoed, md
- Email: mkof@regionsjaelland.dk
- Phone: 0045 93576330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.