Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies (BRIDGE)

September 5, 2025 updated by: Hospital de Clinicas de Porto Alegre

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies: a Double-blind Randomized Study

The goal of this study is to evaluate the efficacy and safety of desmopressin to prevent bleeding after percutaneous renal graft biopsy in patients at high risk of bleeding.

Researchers will compare desmopressin (DDAVP) to placebo to see if the drug reduces the risk of bleeding events related to kidney biopsy.

Participants will receive intravenous desmopressin medication (100ml) or placebo (100mL of saline solution) before the kidney biopsy.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90410000
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Kidney transplant patients with GFR <60ml/min/1,73m²
  • Need for graft biopsy as indicated by the kidney transplant medical team
  • Platelets >80.000 cells/mm³
  • Blood pressure levels controlled before the procedure
  • Normal coagulogram levels

Exclusion Criteria:

  • Pregnant women
  • Prior history of allergic reaction to DDAVP
  • Use of prohibitive medications in screening: warfarin, direct oral anticoagulants, unfractionated and low molecular weight heparin in full anticoagulation doses
  • History of previous blood dyscrasias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sodium Chloride
Drug: Sodium Chloride
Patients in the control group will receive sodium chloride 0.9% 100mL administered as an intravenous infusion 1h before the proposed procedure
Experimental: Desmopressin (DDAVP)
Drug: Desmopressin (DDAVP)
Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding events
Time Frame: Immediately post-biopsy until 48 hours post-biopsy
Incidence of bleeding related to the procedure
Immediately post-biopsy until 48 hours post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding
Time Frame: Immediately post-biopsy until 48 hours post-biopsy
Incidence of major bleeding, defined as need for transfusion of blood components, need for embolization, nephrectomy or procedure-related death
Immediately post-biopsy until 48 hours post-biopsy
Minor bleeding
Time Frame: Immediately post-biopsy until 48 hours post-biopsy
Incidence of minor bleeding, defined as presence of macroscopic hematuria, hematoma on ultrasound 24 hours post-procedure or drop in hemoglobin greater than 20%
Immediately post-biopsy until 48 hours post-biopsy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with hyponatremia, skin reaction, anaphylaxis
Time Frame: Immediately pre-biopsy until 24 hours post-biopsy
Number of participants with hyponatremia, skin reaction, anaphylaxis [Safety and Tolerability]
Immediately pre-biopsy until 24 hours post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Andrea Bauer, MD, PhD, Hospital Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 14, 2026

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

it is not known whether there will be a plan to make IPD available.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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