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

NCT04330729 | Recruiting DMC

• 1 other identifier: REG-018-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to

1. 1.To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how.
2. 2.To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.

Conditions

Erythropoietin Adverse Reaction

Keywords

hemodialysis; platelet function; erythropoietin; thrombosis; anaemia

Outcome Measures

Primary Outcomes (1)

• Thrombocytaggregometry

  Multiplate induced with arachidonic acid, ADP (adenosine diphosphate) and TRAP (Thrombin receptor-activating peptid)

  16 weeks

Secondary Outcomes (11)

• D-dimer

  16 weeks

• MPV

  16 weeks

• Total platelet count

  16 weeks

• PDW

  16 weeks

• IPC

  16 weeks

Study Arms (1)

Dialysis patients

EXPERIMENTAL

Patients will tablet acetylsalicylic acid 75mg x 1 for 4 weeks.

Drug: Acetylsalicylic acid

Interventions

Acetylsalicylic acid DRUG

Se arm description

Dialysis patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Medicinsk afdeling, SUH Roskilde

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Thrombosis; Anemia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James G Heaf

  Department of medicine, Zealand University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Mette KOefoed, md

CONTACT

0045 93576330; mkof@regionsjaelland.dk

Rikke Borg, md, phd

CONTACT

rbor@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 1, 2020
• Study Start: April 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 25, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)