End Stage Renal Disease
Conditions
Brief summary
Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
Interventions
DRUG1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
One bag for nocturnal (long-dwell) exchange.
DRUG0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
One to three, daily (short-dwell) exchanges
Sponsors
Iperboreal Pharma Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * Hemoglobin level ≥ 9g/dL; * 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.
Exclusion criteria
* 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; * History of congestive heart failure stage III and IV New York Heart Association (NYHA); * History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection; * Clinically relevant cardiac arrhythmia; * Clinically relevant abnormalities of functional hepatic tests; * Therapy with L-carnitine or its derivatives in the last three months before selection; * Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception; * Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year; * Participation in another clinical study within the past month; * Known allergic reactions to L-carnitine or xylitol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily ultrafiltration volume | 28 days | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal equilibration test | 28 days | Change from baseline |
| Weekly total urea Kt/V | 28 days | Change from baseline |
| Weekly total creatinine clearance | 28 days | Change from baseline |
| Adverse Events | 2 months | Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate. |
Countries
Italy
Outcome results
None listed