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BleedingPhase 4BRIDGENCT06622187

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

A Phase 4 study testing Desmopressin (DDAVP) and Sodium Chloride in people with Bleeding and Transplant, Kidney, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bleeding, Transplant, Kidney, Desmopressin
What is being tested?
Desmopressin (DDAVP) and Sodium Chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteBrazil
Study dates
14 Aug 2024to 14 Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90410000

Other trials in Brazil

About this study

Official title: 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.

Being tested
Desmopressin (DDAVP), Sodium Chloride
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desmopressin (DDAVP)Drug

    Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure

  • Sodium ChlorideDrug

    Patients in the control group will receive sodium chloride 0.9% 100mL administered as an intravenous infusion 1h before the proposed procedure

Study groups in NCT06622187
Study groupRoleWhat they receive
Sodium ChloridePlacebo comparatorNot described
Receives: Drug: Sodium Chloride
Desmopressin (DDAVP)ExperimentalNot described
Receives: Drug: Desmopressin (DDAVP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding events

    Incidence of bleeding related to the procedure

    Measured: Immediately post-biopsy until 48 hours post-biopsy

Secondary outcomes (2)

  1. Major bleeding

    Incidence of major bleeding, defined as need for transfusion of blood components, need for embolization, nephrectomy or procedure-related death

    Measured: Immediately post-biopsy until 48 hours post-biopsy

  2. Minor bleeding

    Incidence of minor bleeding, defined as presence of macroscopic hematuria, hematoma on ultrasound 24 hours post-procedure or drop in hemoglobin greater than 20%

    Measured: Immediately post-biopsy until 48 hours post-biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start14 Aug 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completion14 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06622187
Sponsor's protocol ID
2024-0270
Acronym
BRIDGE
Status last verified
Aug 2025
First submitted
3 Sep 2024
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: it is not known whether there will be a plan to make IPD available.

Publications

  • Sethi J, Bansal S, Lal A, Kohli HS, Rathi M. Role of Desmopressin Acetate before Percutaneous Ultrasound-Guided Kidney Biopsy in Patients with Kidney Dysfunction. Indian J Nephrol. 2024 May-Jun;34(3):228-232. doi: 10.4103/ijn.ijn_34_23. Epub 2023 Sep 29.

    PubMed 39114394

  • Leclerc S, Nadeau-Fredette AC, Elftouh N, Lafrance JP, Pichette V, Laurin LP. Use of Desmopressin Prior to Kidney Biopsy in Patients With High Bleeding Risk. Kidney Int Rep. 2020 May 20;5(8):1180-1187. doi: 10.1016/j.ekir.2020.05.006. eCollection 2020 Aug.

    PubMed 32775817

  • Sattari SA, Shahoori A, Shahbazian H, Sabetnia L, Aref A, Sattari AR, Ghorbani A. Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial. Iran J Kidney Dis. 2022 Jul;16(4):238-245.

    PubMed 35962638

  • Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26.

    PubMed 21354681

  • Mannucci PM, Remuzzi G, Pusineri F, Lombardi R, Valsecchi C, Mecca G, Zimmerman TS. Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia. N Engl J Med. 1983 Jan 6;308(1):8-12. doi: 10.1056/NEJM198301063080102.

    PubMed 6401193

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Desmopressin (DDAVP) and Sodium Chloride in people with Bleeding and Transplant, Kidney, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding events (time frame: Immediately post-biopsy until 48 hours post-biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06622187, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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