L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

What Was Tested

The trial (phase 2) is built around L-Carnitine.

Study hypothesis is to evaluate the possibility to formulate PD solutions containing L-carnitine as an osmotic agent to partially replace glucose.

It had 1 arm (groups): PD solution (experimental).

The registry classes the interventions as drug.

Who Took Part

5 actual participants took part.

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: Age ≥18 years. Have not experienced peritonitis episodes in the last 3 months. Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit. Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: have a history of drug or alcohol abuse in the six months prior to entering the protocol; be in treatment with androgens; have diabetes mellitus (as defined by the american diabetes society, objectively documented by a fasting plasma glucose and hba1c determinations).

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

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

It started in 2009-06 with completion listed for 2012-10.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of L-Carnitine in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.