NCT05467033 Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
| NCT ID | NCT05467033 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Medical University of Bialystok |
| Condition | Kidney Biopsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 424 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 424 participants in total. It began in 2022-09-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Alicja Rydzewska-Rosołowska, Assoc.Prof.
PRINCIPAL INVESTIGATOR
Second Department of Nephrology and Hypertension with Dialysis Unit
Frequently Asked Questions
Who can join the NCT05467033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Kidney Biopsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05467033 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 424 participants.
Is NCT05467033 currently recruiting?
Yes, NCT05467033 is actively recruiting participants. Contact the research team at alicja.rydzewska-rosolowska@umb.edu.pl for enrollment information.
Where is the NCT05467033 trial being conducted?
This trial is being conducted at Bialystok, Poland.
Who is sponsoring the NCT05467033 clinical trial?
NCT05467033 is sponsored by Medical University of Bialystok. The principal investigator is Alicja Rydzewska-Rosołowska, Assoc.Prof. at Second Department of Nephrology and Hypertension with Dialysis Unit. The trial plans to enroll 424 participants.
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