Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin (STOP-BLEED)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Biopsy
• Intervention / Treatment: Drug: Desmopressin; Drug: intravenous infusion NaCl

Detailed Description

Glomerulonephritis (GN) are rare diseases which carry a high risk of morbidity and mortality. Very often it is diagnosed in the late stage of a disease. One of the reasons might be the fact of a concern for potential complications which might arise from kidney biopsy which is the only procedure which can confirm a diagnosis of glomerulonephritis. According to the map of health needs for Poland the estimated incidence of glomerulonephritis is 40.6 thousand people per year and approximately 1,250 percutaneous renal biopsy (PRB) are performed annually in the adult population.

There are few other studies which analyse the effect of DDAVP administration on the incidence of post-biopsy bleeding events in patients undergoing ultrasound guided PRB without previous coagulopathy. However, there were controversies regarding the potential side effects of DDAVP22 as the studies included only native kidneys biopsies Therefore, a clinical trial is planned with an adequately statistically powered sample of high-risk patients is planned Patients above 18 years old, already qualified by a nephrologist for a kidney biopsy will be randomized with random permuted blocks method into two equal groups (212 patients each) - in one 0,3 micrograms/kg i.v. of desmopressin (in 100 ml of 0,9% NaCl) will be administered one hour before procedure, in the second placebo only (100 ml of 0,9% NaCl). Kidney biopsy will be performed according to standard procedures by an experienced nephrologist with the use of 16G needles during a standard hospitalization with 48 hours of observation. The investigators will assess minor and major bleeding events occurring in the first 24 hours after the procedure (minor: macroscopic haematuria, clinically silent hematoma on kidney ultrasound performed 24 hours after the procedure, haemoglobin decrease above 20% from baseline; major: blood transfusion, embolization, nephrectomy, death indirectly or directly caused by the procedure) and for safety reasons the occurrence of hyponatremia 24 and 48 hours after kidney biopsy

• Study Type: Interventional
• Enrollment (Estimated): 424
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alicja Rydzewska-Rosołowska, Assoc.Prof.; Phone Number: +48 604 330 187; Email: alicja.rydzewska-rosolowska@umb.edu.pl

Study Locations

• Poland
  • Bialystok, Poland, 15-276
    • Recruiting
    • II Department of Nephrology and Hypertension
    • Contact: Alicja Rydzewska-Rosolowska, MD; Phone Number: +48858317885; Email: alicja.rosolowska@umb.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;	Drug: Desmopressin; desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; Other Names: Minirin; Drug: intravenous infusion NaCl; 0,9% NaCl managed as intravenous infusion; Other Names: 0,9% NaCl
Placebo Comparator: Placebo comparator; 0,9% NaCl managed as intravenous infusion;	Drug: intravenous infusion NaCl; 0,9% NaCl managed as intravenous infusion; Other Names: 0,9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events in 24 hours after the procedure	Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline.; 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	Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline.; Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.	48 hours after kidney biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization	Hospitalization time from kidney biopsy till discharge	4 years

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Investigators: Principal Investigator: Alicja Rydzewska-Rosołowska, Assoc.Prof., Second Department of Nephrology and Hypertension with Dialysis Unit

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hemostatics; Coagulants; Natriuretic Agents; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 2021/ABM/01/00100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified information will be shared upon asking.
• IPD Sharing Time Frame: Immediately following publication up to 5 years after.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No