| Trial ID: | L0056 |
| Source ID: | NCT06492031
|
| Associated Drug: |
Icodextrin Peritoneal Dialysis Solution
|
| Title: |
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
|
| Acronym: |
oSCAR
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: Icodextrin Peritoneal Dialysis Solution|DRUG: Glucose Peritoneal Dialysis Solution
|
| Outcome Measures: |
Primary: Comparison of the incidence of a composite endpoint for technique failure and death, Technique failure is defined as: * Treatment transferred from PD to HD/PHD \> 30 days; or * PHD defines as adding HD treatment at least once every 2 weeks in 30 days during PD, Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD, 12 months | Secondary: Comparison of the proportion of patients with technique failure, Number and proportion of patients with technique failure, 12 months|Comparison of the incidence of cardiovascular events, Cardiovascular events include acute myocardial infarction, sudden severe arrhythmia ( a trial fibrillation and arrhythmia requiring hospitalization or medication), hospitalization for heart failure, stroke, and cardiovascular death., 12 months|Comparison of the incidence of the changes in ejection fraction, Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF）, 12 months|Comparison of all-cause deaths, All-cause deaths refer to the total number of deaths from any cause within the study timeframe, 12 months|Comparison of medical resource utilization in terms of hospitalizations, Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only, 12 months|Comparison of annual exchange dosage of ICO, For ICO group only, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Vantive Health LLC | Collaborators: Baxter Healthcare Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
889
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2024-06-28
|
| Completion Date: |
2026-03
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-18
|
| Locations: |
Beijing Haidian Hospital, Beijing, 100000, China|Hangzhou Hospital Of Traditional Chinese Medicine, Hangzhou, 310007, China|The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010000, China|Nanjing Drum Tower Hospital, Jiangse, 210008, China|Wuxi People's Hospital, Jiangse, 214023, China|The First People's Hospital of Kunshan, Jiangse, 215300, China|Ningbo First Hospital, Ningbo, 315000, China|Shanghai General Hospital, Shanghai, 200080, China|Renji Hospital Shanghai Jaotong University School of Medicine, Shanghai, 200120, China|The Second Affiliated Hospital of Soochow University, Suzhou, 215004, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06492031
|
