| Trial ID: | L0812 |
| Source ID: | NCT04086212
|
| Associated Drug: |
Icodextrin, Xylitol And Carnitine Solution For Peritoneal Dialysis
|
| Title: |
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
|
| Acronym: |
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| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: Icodextrin, xylitol and carnitine solution for peritoneal dialysis|DRUG: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
|
| Outcome Measures: |
Primary: Net-ultrafiltration, Net Ultrafiltration at 10 hours (duration of long dwell), in mL, is defined as the difference between the weight of drained volume and weight of the effluent (fill volume)., Changes from baseline value at the end of each product administration period (3 days) | Secondary: Sodium removal, Net sodium removal will be calculated as the difference between the total amount of sodium drained at end of long dwell (10 hours) and its measure value in the dialysate at time 0 before the initial infusion. Sodium will determined by the hospital laboratory., Calculated every day for 3 days during each product administration period.|Carnitine plasmatic level, Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples., Every day for 3 days during each product administration and during the wash-out period|Xylitol plasmatic level, Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples., Every day for 3 days during each product administration and during the wash-out period.|Xylitol absorption, Xilitol absorption is determined by calculating the difference (in grams) between the amount of xylitol (measured by lab analysis) in plasma and the amount of xylitol in the patient's dialysis solution administered., Every day for 3 days during each product administration|Adverse Events, Through study completion, an average of 21 days.
|
| Sponsor/Collaborators: |
Sponsor: Iperboreal Pharma Srl
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-10-02
|
| Completion Date: |
2023-04
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-01
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04086212
|
