Clinical Trial Details
| Trial ID: | L0836 |
| Source ID: | NCT01779557 |
| Associated Drug: | Huaren Peritoneal Dialysate |
| Title: | Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate |
| Acronym: | SEED |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Kidney Failure,Chronic |
| Interventions: | DRUG: Huaren Peritoneal Dialysate|DRUG: Baxter Peritoneal Dialysate |
| Outcome Measures: | Primary: survival rate, 1,2,3,4,5 years | Secondary: PD technique survival rate, 1,2,3,4,5 years|estimated glomerular filtration rate decline, 1,2,3,4,5 years|nutritional status, 1,2,3,4,5 years|quality of life(SF-36), 1,2,3,4,5 years|cardiovascular events, 1,2,3,4,5 years|increments of dialysis dose, 1,2,3,4,5 years|medical costs, 1,2,3,4,5 years|dropout rate, 1,2,3,4,5 years | Other: AE, vital signs, laboratory tests, 1,2,3,4,5 years|peritonitis, 1,2,3,4,5 years|quality of products, 1,2,3,4,5 years|allergy to PD fluids, bags and tubes, 1,2,3,4,5 years |
| Sponsor/Collaborators: | Sponsor: Chinese PLA General Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 750 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-02 |
| Completion Date: | 2021-09 |
| Results First Posted: | |
| Last Update Posted: | 2022-03-10 |
| Locations: | Chinese PLA General Hospital, Beijing, Beijing, 100853, China |
| URL: | https://clinicaltrials.gov/show/NCT01779557 |
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