RecruitingPhase 3NCT05467033
Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
Sponsor
Medical University of Bialystok
Enrollment
424 participants
Start Date
Sep 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria8
- ≥ 18 years old
- Ability to provide Informed Consent
- Qualification by nephrologist to kidney biopsy in accordance to current standards
- Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/μL
- Normal range of APTT and INR
- Blood pressure control defined as SBP<160 mmHg
- Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin
- No inflammation at the point of biopsy needle insertion
Exclusion Criteria15
- Initial sodium concentration <130mmol/l
- Pregnancy and breastfeeding
- Anaphylactic shock after desmopressin administration (medical history)
- Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
- Decompensated Heart failure
- Von Willebrand disease (VWD) type II B
- As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
- Hydronephrosis of the biopsied kidney
- 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
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Interventions
DRUGDesmopressin
desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;
DRUGintravenous infusion NaCl
0,9% NaCl managed as intravenous infusion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05467033