To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors

What Was Tested

This registered phase 4 trial tested Desmopressin.

It had 1 arm (groups): Desmopressin (experimental).

All ten subjects will be evaluated pre and post nephrectomy at 6 months.

The registry classes the interventions as drug.

More on the Plan

The physiologic sequelae of living kidney donation are still poorly understood.

The goal of this study is to evaluate the effect of uni-nephrectomy on renal tubular function and its potential in being an early and more sensitive marker in kidney injury when compared to standard tests.

Who Took Part

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Only patients who are able to sign their own consent form may be included in this study. Subjects must be able and willing, in the investigator's opinion, to complete all study requirements.

The full record lists 3 inclusion and 2 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-08-29 with completion listed for 2019-04-26.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Percentage change in tubular function (urine osmolality measured in MOSMOL/K) pre and post nephrectomy as assessed through water deprivation and administration of desmopressin (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL, Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML and Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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