| Trial ID: | L0808 |
| Source ID: | NCT04001036
|
| Associated Drug: |
1.5% Xylitol, 0.5% Glucose, And 0.02% L-Carnitine
|
| Title: |
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine|DRUG: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
|
| Outcome Measures: |
Primary: Daily ultrafiltration volume, Change from baseline, 28 days | Secondary: Peritoneal equilibration test, Change from baseline, 28 days|Weekly total urea Kt/V, Change from baseline, 28 days|Weekly total creatinine clearance, Change from baseline, 28 days|Adverse Events, 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., 2 months
|
| Sponsor/Collaborators: |
Sponsor: Iperboreal Pharma Srl
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-01
|
| Completion Date: |
2022-08-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-03
|
| Locations: |
Department of Nephrology, University of Chieti, Chieti, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT04001036
|
