Evaluating desmopressin for preventing bleeding after kidney biopsy

Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin

This study is testing if a medication called desmopressin can help prevent bleeding after kidney biopsies in adults with rare kidney diseases.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Medical University of Bialystok (Academic / other)
• Locations: 1 site (Bialystok)
• Trial ID: NCT05467033 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been referred for a kidney biopsy due to suspected glomerulonephritis.

Not a fit: Patients with conditions such as severe hyponatremia, pregnancy, or a history of anaphylactic shock to desmopressin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of bleeding complications after kidney biopsies, improving patient safety and outcomes.

How similar studies have performed: Previous studies have explored the effects of desmopressin on post-biopsy bleeding, but this trial aims to provide more robust data in a high-risk population, making it a novel approach.

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

Where this trial is running

Bialystok

• 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.

Conditions Kidney Biopsy