The influence of renal function on the amount of nadroparin in blood

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2011-002128-41-NL
• Date of registration: 08/06/2011
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: The influence of renal function on the amount of nadroparin in blood
• Scientific title: Accumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels - ANURIA
• Date of first enrolment: 12/07/2011
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002128-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Netherlands

Contacts

• Name: Hospital Pharmacy
• Affiliation: Erasmus MC

• Name: Hospital Pharmacy
• Affiliation: Erasmus MC

Key inclusion & exclusion criteria

Inclusion criteria:
- Age at least 18 years
- First day of high-prophylactic treatment with nadroparin
- GFR (based on Modification of Diet in Renal Disease (MDRD) calculation) 10-20 ml/min, 20-30 ml/min, 30-40 ml/min, 40-50 ml/min or 50 ml/min or higher (equal distribution of patients to be included over these 5 groups)
- High-prophylactic treatment dose of nadroparin of 5,700 anti-Xa activity IU once daily
- Subcutaneous nadroparin administration for at least 3 days
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
- Patients on an intensive care unit (ICU)
- Normal prophylactic dosages or therapeutic dosages of nadroparin for VTE
- GFR less than 10 ml/ml or dialysis
- Severe liver failure
- Pregnant patients or patients giving breast feeding
- Nadroparin in use for more than 2 days
- Adjustment of the dosage of nadroparin without measuring of anti-Xa level


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Venous thromboembolism

Intervention(s)

Trade Name: Fraxiparine
Product Name: Fraxiparine
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: nadroparin
CAS Number: 9041-08-1
Other descriptive name: nadroparin
Concentration unit: anti-Xa IU anti-Xa activity International Unit(s)
Concentration type: equal
Concentration number: 5700-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: After day 5 of treatment with nadroparin

Main Objective: Anti-Xa levels will be measured 4 hours (± 1 hour) after subcutaneous injection of nadroparin on day 1 or day 2, day 3 and day 5 of treatment (if applicable day 10 of treatment). Primary outcome is the degree of accumulation, defined as the percentage of increase of anti-Xa level on day 5 compared to day 1. This primary outcome will be assessed for various levels of renal function

Primary end point(s): Anti-Xa levels will be measured 4 hours (± 1 hour) after subcutaneous injection of nadroparin on day 1 or day 2, day 3 and day 5 (if applicable day 10) of treatment. Primary outcome is the degree of accumulation, defined as the percentage of increase of anti-Xa level on day 5 compared to day 1. This primary outcome will be assessed for various levels of renal function.

Secondary Objective: Secondary endpoints are the percentage of increase of anti-Xa level on day 3 compared to day 1, the percentage of increase of anti-Xa level on day 10 compared to day 1, and bleeding complications during treatment with nadroparin.

Secondary Outcome(s)

Secondary end point(s): Secondary endpoints are the percentage of increase of anti-Xa level on day 3 compared to day 1, the percentage of increase of anti-Xa level on day 10 compared to day 1, and bleeding complications during treatment with nadroparin.

Timepoint(s) of evaluation of this end point: After day 1 and day 10 of treatment with nadroparin

Secondary ID(s)

RyB001

NTR2850

Source(s) of Monetary Support

Erasmus MC