L-Carnitine in Peritoneal Dialysis

What Was Tested

In this phase 2 trial, researchers set out to test L-Carnitine.

The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.

It had 1 arm (groups): Peritoneal Dialysis Solution (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4 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 a diagnosis of End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis for at least 3 months. 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.

The full record lists 12 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 non-randomized, 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 2004-06 with completion listed for 2004-10.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Long Dwell Ultrafiltration (time frame: day 5).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of L-Carnitine in 4 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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