Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin

What Was Tested

The trial (phase 3) is built around Desmopressin.

It had two arms (groups): Experimental (experimental) and Placebo comparator (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Glomerulonephritis (GN) are rare diseases which carry a high risk of morbidity and mortality.

Very often it is diagnosed in the late stage of a disease.

One of the reasons might be the fact of a concern for potential complications which might arise from kidney biopsy which is the only procedure which can confirm a diagnosis of glomerulonephritis.

According to the map of health needs for Poland the estimated incidence of glomerulonephritis is 40.6 thousand people per year and approximately 1,250 percutaneous renal biopsy (PRB) are performed annually in the adult population.

Who Took Part

424 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: ≥ 18 years old. Ability to provide Informed Consent. Qualification by nephrologist to kidney biopsy in accordance to current standards. Normal range of APTT and INR. Blood pressure control defined as SBP\<160 mmHg.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: pregnancy and breastfeeding; necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin; decompensated heart failure.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Desmopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-09-01 with completion listed for 2026-08-31.

It ran at 1 site in Poland.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Bleeding events in 24 hours after the procedure (time frame: 24 hours after kidney biopsy). Bleeding events in 48 hours after the procedure (time frame: 48 hours after kidney biopsy).

It also tracked 1 secondary outcome, for example Length of hospitalization.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 424 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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