| Trial ID: | L0083 |
| Source ID: | NCT02681952
|
| Associated Drug: |
Renamezin Capsule
|
| Title: |
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: Renamezin capsule|DRUG: Kremezin granule
|
| Outcome Measures: |
Primary: Preference of formulation, questionnaire, 24weeks | Secondary: Serum Creatinine, 12weeks, 24weeks|Serum Indoxyl sulfate, 12weeks, 24weeks|Cystatin-C, 12weeks, 24weeks|estimated GFR(Glomerular Filtration Rate), MDRD GFR, 12weeks, 24weeks
|
| Sponsor/Collaborators: |
Sponsor: Daewon Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
153
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2015-12
|
| Completion Date: |
2016-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-06
|
| Locations: |
Sevrance Hospital of Yonsei University, Seoul, Seodaemun, 03722, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02681952
|
