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Extraneal Physiological pH vs Standard Extraneal in CAPD
NCT00214721Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2005
- Countries
- 1
- Sponsor
- Vanttive
- Modality
- Polymer-based Nanoparticles, Device-based Delivery
- Drugs
- icodextrin
- Conditions
- end stage renal disease (ESRD)
01
Overview
Phase 3, randomised, open-label trial of icodextrin in end stage renal disease (ESRD) (2 arms), sponsored by Vanttive. Primary endpoint: Inflow Pain. Started Feb 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Extraneal Physiological pH
Icodextrin solution with bicarbonate/lactate buffer
Standard Extraneal
Standard Icodextrin solution with lactate buffer
03
Endpoints
Primary
Inflow Pain
Secondary
Long Dwell Peritoneal Creatinine Clearance
Acid-Base Status
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