End-Stage Kidney Disease
Conditions
Brief summary
Adverse Events (during the whole study), Physical Examination (at every visit), Vital Signs and body weight (at every visit), Blood chemistry and hematology (at every visit), 24h diuresis analysis (at every visit), 24h dialysate analysis (at every visit), Weekly Kt/V urea (evaluated at every visit), Residual kidney function (at every visit)
Detailed description
Post-baseline profile of weekly Kt/V urea (at every visit), Peritoneal ultrafiltration (at every visit and daily by patient diary), Peritoneal and total sodium removal (at every visit), Glycemic and lipidic parameters (at every visit), Peritoneal clearances: creatinine, phosphate, B2-microglobulin, (at every visit), Quality of Life: KDQOL-SF (V2, V4), N° of patients who dropped-out from the study for safety and efficacy reasons
Interventions
DRUGPolyCore
Sponsors
Iperboreal Pharma S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (during the whole study), Physical Examination (at every visit), Vital Signs and body weight (at every visit), Blood chemistry and hematology (at every visit), 24h diuresis analysis (at every visit), 24h dialysate analysis (at every visit), Weekly Kt/V urea (evaluated at every visit), Residual kidney function (at every visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-baseline profile of weekly Kt/V urea (at every visit), Peritoneal ultrafiltration (at every visit and daily by patient diary), Peritoneal and total sodium removal (at every visit), Glycemic and lipidic parameters (at every visit), Peritoneal clearances: creatinine, phosphate, B2-microglobulin, (at every visit), Quality of Life: KDQOL-SF (V2, V4), N° of patients who dropped-out from the study for safety and efficacy reasons | — |
Countries
Italy
Outcome results
None listed