Evaluating desmopressin for preventing bleeding after kidney biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, multicenter, double-blind, placebo-controlled evaluation of desmopressin's effectiveness in preventing bleeding complications following percutaneous needle kidney biopsy in patients diagnosed with rare forms of glomerulonephritis. Conducted in Poland across six hospital nephrology departments, the study will enroll patients who are 18 years or older and have been qualified for a kidney biopsy. Participants will be randomly assigned to receive either desmopressin or a placebo prior to the procedure, with the aim of assessing safety and efficacy in a high-risk population. The trial seeks to address concerns regarding the risks associated with kidney biopsies, which are critical for diagnosing glomerulonephritis.

Why it matters

Who can join: the full rules

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

Where it's running

• II Department of Nephrology and Hypertension
  Bialystok, Poland Recruiting

Study contacts

• Principal investigator: Alicja Rydzewska-Rosołowska, Assoc.Prof. — Second Department of Nephrology and Hypertension with Dialysis Unit
• Study coordinator: Alicja Rydzewska-Rosołowska, Assoc.Prof.
• Email: alicja.rydzewska-rosolowska@umb.edu.pl
• Phone: +48 604 330 187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.