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Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

Plain-language guide to NCT06622187: phase 4 randomized trial of Desmopressin, 96 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06622187
Phase
phase 4
Status
enrolling by invitation
Start
2024-08-14
Completion (planned or actual)
2026-06
Participants
96 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Bleeding; Transplant, Kidney; Desmopressin; Kidney Biopsy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Desmopressin.

It had two arms (groups): Sodium Chloride (placebo comparator) and Desmopressin (DDAVP) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 96 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: pregnant women; prior history of allergic reaction to ddavp; history of previous blood dyscrasias.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

The Desmopressin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-08-14 with completion listed for 2026-06.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bleeding events (time frame: Immediately post-biopsy until 48 hours post-biopsy).

It also tracked 2 secondary outcomes, for example Major bleeding and Minor bleeding.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Desmopressin in 96 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.

Our Notes on the Compound

Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.