Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT05467033
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old
2. Ability to provide Informed Consent
3. Qualification by nephrologist to kidney biopsy in accordance to current standards
4. Initial haemoglobin concentration \> 8g/dl and PLT count \>100 x103/μL
5. Normal range of APTT and INR
6. Blood pressure control defined as SBP\<160 mmHg
7. Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin
8. No inflammation at the point of biopsy needle insertion
Exclusion Criteria:
1. Initial sodium concentration \<130mmol/l
2. Pregnancy and breastfeeding
3. Anaphylactic shock after desmopressin administration (medical history)
4. Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
5. Decompensated Heart failure
6. Von Willebrand disease (VWD) type II B
7. As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
8. Hydronephrosis of the biopsied kidney
9. Usage of any prohibited drug before screening :
* ASA in dosage \> 75mg per day
* Vitamin K antagonist (VKA)
* Direct oral anticoagulants (DOAC)
* Low-molecular-weight heparin (LMWH)
* Unfractionated heparin (UFH)
* Except situation when dosage of listed above drugs will be adjusted in accordance to protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05467033
Study Brief:
Protocol Section:
NCT05467033