Ended Therapeutic confirmatory (Phase III) Rare and ultra-rare glomerulonephritis

Efficacy of Desmopressin in safaty outcomes post kindey biopsy

EU CTIS ID: 2024-516270-30-00

What this study is testing

Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for bleeding prevention.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥ 18 years old
  • Ability to provide Informed Consent
  • Qualification by nephrologist to kidney biopsy in accordance to current standards - transplanted kidney biopsy is not allowed.
  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • ≥ 18 years old
  • Ability to provide Informed Consent
  • Qualification by nephrologist to kidney biopsy in accordance to current standards - transplanted kidney biopsy is not allowed.
  • 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 non-fractionated or low molecular weight heparin.
  • No inflammation at the point of biopsy needle insertion
What rules you out
  • 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); except situation when dosage of listed above drugs will be adjusted in accordance to protocol.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.