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New treatment option for Erythropoietin Adverse Reaction
Official title The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp
ClinicalTrials.gov ID: NCT04330729
What this study is testing
What is Acetylsalicylic acid?
Acetylsalicylic acid is an investigational medicine, given as an once-daily, being studied as a potential treatment for erythropoietin adverse reaction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
- aged 18-85
- indication for treatment with Erythropoiesis-stimulating agents (ESA)
You likely can't join 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...
- 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
See the full eligibility criteria
- Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
- aged 18-85
- indication for treatment with Erythropoiesis-stimulating agents (ESA)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roskilde, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roskilde, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.