E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After day 5 of treatment with nadroparin |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After day 1 and day 10 of treatment with nadroparin |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |