Actively Recruiting
Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
Led by Medical University of Bialystok · Updated on 2025-05-08
424
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Ability to provide informed consent
- Qualified by a nephrologist for kidney biopsy according to current standards
- Initial hemoglobin concentration greater than 8 g/dl and platelet count above 100 x10³/µL
- Normal activated partial thromboplastin time (APTT) and international normalized ratio (INR)
- Controlled blood pressure with systolic blood pressure under 160 mmHg
- Allowed use of acetylsalicylic acid and heparin as antiplatelet/antithrombotic drugs
- No inflammation at the biopsy needle insertion site
You will not qualify if you...
- Initial sodium concentration below 130 mmol/l
- Pregnancy or breastfeeding
- History of anaphylactic shock after desmopressin administration
- Need for antiplatelet or antithrombotic drugs other than acetylsalicylic acid, non-fractionated heparin, or low molecular weight heparin
- Decompensated heart failure
- Von Willebrand disease type II B
- Medical conditions increasing risk of raised intracranial pressure as judged by investigator
- Hydronephrosis of the kidney to be biopsied
- Use of prohibited drugs before screening including ASA over 75 mg/day, vitamin K antagonists, direct oral anticoagulants, low-molecular-weight heparin, or unfractionated heparin unless adjusted per protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
II Department of Nephrology and Hypertension
Bialystok, Poland, 15-276
Actively Recruiting
Research Team
A
Alicja Rydzewska-Rosołowska, Assoc.Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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