End-stage Kidney Disease
Conditions
Brief summary
Safety assesses on the basis of continuous Adverse Events reporting, including evaluation of blood pressure and weight
Detailed description
Kt/V urea (V2 and V3), 24h Peritoneal ultrafiltration (V2 and V3), 24h urinary volume (V2 and V3), Peritoneal Equilibration Test (V2 and V3), Residual Kidney Function (V2 and V3), Plasma L-carnitine (V1, V2 and V3), Tolerability assessment - blood chemistry and hematology (V2, V3, V4)
Interventions
DRUGGLUCOTHERA PLUS
Sponsors
Iperboreal Pharma S.r.l., Iperboreal Pharma S.r.l.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assesses on the basis of continuous Adverse Events reporting, including evaluation of blood pressure and weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Kt/V urea (V2 and V3), 24h Peritoneal ultrafiltration (V2 and V3), 24h urinary volume (V2 and V3), Peritoneal Equilibration Test (V2 and V3), Residual Kidney Function (V2 and V3), Plasma L-carnitine (V1, V2 and V3), Tolerability assessment - blood chemistry and hematology (V2, V3, V4) | — |
Countries
Italy
Outcome results
None listed