Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

NCT06622187 | Enrolling By Invitation Phase 4

• 1 other identifier: 2024-0270
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bleeding; Transplant, Kidney; Desmopressin; Kidney Biopsy

Outcome Measures

Primary Outcomes (1)

• Bleeding events

  Incidence of bleeding related to the procedure

  Immediately post-biopsy until 48 hours post-biopsy

Secondary Outcomes (2)

• Major bleeding

  Immediately post-biopsy until 48 hours post-biopsy

• Minor bleeding

  Immediately post-biopsy until 48 hours post-biopsy

Other Outcomes (1)

• Number of participants with hyponatremia, skin reaction, anaphylaxis

  Immediately pre-biopsy until 24 hours post-biopsy

Study Arms (2)

Sodium Chloride

PLACEBO COMPARATOR

Drug: Sodium Chloride

Desmopressin (DDAVP)

EXPERIMENTAL

Drug: Desmopressin (DDAVP)

Interventions

Desmopressin (DDAVP) DRUG

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

Desmopressin (DDAVP)

Sodium Chloride DRUG

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

Sodium Chloride

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410000, Brazil

Location

Related Publications (5)

• 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.

  PMID: 39114394 BACKGROUND

• 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.

  PMID: 32775817 BACKGROUND

• 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.

  PMID: 35962638 BACKGROUND

• 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.

  PMID: 21354681 BACKGROUND

• 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.

  PMID: 6401193 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Deamino Arginine Vasopressin; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andrea Bauer, MD, PhD

  Hospital Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 2, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-08

Locations

BR (1)