Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

What Was Tested

This registered phase 2 trial tested L-Carnitine.

Prospective, randomized, controlled clinical trial.

Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD).

It had two arms (groups): Experimental peritoneal dialysis solution IPX15 (experimental) and Experimental peritoneal dialysis solution IPX07 (experimental).

Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.

Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.

The registry classes the interventions as drug.

Who Took Part

The registry lists 11 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: Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;. Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;. Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;. To understand and sign an informed consent form.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: history of alcohol or drug abuse in the last six months before selection for the study;; androgen therapy in the last six months before selection;; active infections;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the L-Carnitine study did not mask who received what.

It started in 2019-09-01 with completion listed for 2022-08-30.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Daily ultrafiltration volume (time frame: 28 days).

It also tracked 4 secondary outcomes, for example Peritoneal equilibration test, Weekly total urea Kt/V, Weekly total creatinine clearance and Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 11 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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