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Search / Trial NCT04330729

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

Launched by ZEALAND UNIVERSITY HOSPITAL · Mar 30, 2020

Trial Information

Current as of July 06, 2025

Recruiting

Keywords

Hemodialysis Platelet Function Erythropoietin Thrombosis Anaemia

ClinConnect Summary

This clinical trial is studying how a medication called Aranesp®, which helps boost red blood cell production, affects the function of platelets in patients with chronic kidney disease (CKD). Specifically, the researchers want to see if adding another treatment, salicylate, changes how Aranesp® impacts platelets. Platelets are important for blood clotting, so understanding this interaction is crucial for ensuring patient safety and effective treatment.

To participate in the study, individuals must be between 18 and 85 years old and have CKD requiring treatment with erythropoiesis-stimulating agents like Aranesp®. However, there are some important criteria that would exclude a person from participating, such as having certain allergies, being on specific blood-thinning medications, or having active cancer. Participants will undergo regular assessments to monitor their health and the effects of the treatments. This study is currently recruiting, so there is an opportunity for eligible patients to contribute to valuable research that could improve care for those with kidney disease.

Gender

ALL

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.

About Zealand University Hospital

Zealand University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to improve patient outcomes and enhance treatment methodologies. With a commitment to rigorous scientific standards and ethical practices, Zealand University Hospital collaborates with multidisciplinary teams to explore new therapies and interventions, contributing significantly to the global body of medical knowledge. Through its state-of-the-art facilities and focus on patient-centered care, the hospital plays a pivotal role in shaping the future of medicine.

Locations

Roskilde, , Denmark

Patients applied

0 patients applied

Trial Officials

James G Heaf

Study Director

Department of medicine, Zealand University Hospital, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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