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Enrolling by invitationNCT06622187BRIDGEUpdated Sep 11, 2025

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

A Phase 4 interventional study of Desmopressin (DDAVP) and Sodium Chloride in Bleeding, Transplant, Kidney and Desmopressin, sponsored by Hospital de Clinicas de Porto Alegre. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as enrolling by invitation.
Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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

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Conditions studied

  • Bleeding
  • Transplant, Kidney
  • Desmopressin
  • Kidney Biopsy

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In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 96 is close to the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Placebo comparator
    Sodium Chloride

    Drug: Sodium Chloride

  • Experimental
    Desmopressin (DDAVP)

    Drug: Desmopressin (DDAVP)

Interventions

  • DrugDesmopressin (DDAVP)

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

  • DrugSodium Chloride

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

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What researchers measure

Primary outcomes

  1. Bleeding events

    Incidence of bleeding related to the procedure

    Time frame: Immediately post-biopsy until 48 hours post-biopsy

Secondary outcomes

  1. Major bleeding

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

    Time frame: 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%

    Time frame: Immediately post-biopsy until 48 hours post-biopsy

Other outcomes

  1. Number of participants with hyponatremia, skin reaction, anaphylaxis

    Number of participants with hyponatremia, skin reaction, anaphylaxis \[Safety and Tolerability\]

    Time frame: Immediately pre-biopsy until 24 hours post-biopsy

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Study locations

1 site
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90410000, Brazil
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided — it is not known whether there will be a plan to make IPD available.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06622187
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Oct 2, 2024
Start date
Aug 14, 2024
Primary completion
Jun 2026 (estimated)
Completion
Jun 14, 2026 (estimated)
Last update
Sep 11, 2025

Study contacts

Andrea Bauer, MD, PhD
principal investigator · Hospital Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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