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

NCT05467033 | Recruiting Phase 3 DMC

• 1 other identifier: 2021/ABM/01/00100
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Biopsy

Outcome Measures

Primary Outcomes (2)

• Bleeding events in 24 hours after the procedure

  1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration \>20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.

  24 hours after kidney biopsy

• Bleeding events in 48 hours after the procedure

  1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration \>20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.

  48 hours after kidney biopsy

Secondary Outcomes (1)

• Length of hospitalization

  4 years

Study Arms (2)

Experimental

EXPERIMENTAL

0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;

Drug: Desmopressin; Drug: intravenous infusion NaCl

Placebo comparator

PLACEBO COMPARATOR

0,9% NaCl managed as intravenous infusion;

Drug: intravenous infusion NaCl

Interventions

Desmopressin DRUG

desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;

Also known as: Minirin

Experimental

intravenous infusion NaCl DRUG

0,9% NaCl managed as intravenous infusion

Also known as: 0,9% NaCl

Experimental; Placebo comparator

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Ability to provide Informed Consent
• Qualification by nephrologist to kidney biopsy in accordance to current standards
• 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 heparin
• No inflammation at the point of biopsy needle insertion

You may not qualify 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
• 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)
• Low-molecular-weight heparin (LMWH)
• Unfractionated heparin (UFH)
• Except situation when dosage of listed above drugs will be adjusted in accordance to protocol

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

II Department of Nephrology and Hypertension

Bialystok, 15-276, Poland

RECRUITING

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Alicja Rydzewska-Rosołowska, Assoc.Prof.

  Second Department of Nephrology and Hypertension with Dialysis Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicja Rydzewska-Rosołowska, Assoc.Prof.

CONTACT

+48 604 330 187; alicja.rydzewska-rosolowska@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication up to 5 years after.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

PL (1)