Clinical Trial Details
| Trial ID: | L1656 |
| Source ID: | NCT04059913 |
| Associated Drug: | Roxadustat |
| Title: | Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | CKD Anemia in Dialysis Participants |
| Interventions: | DRUG: Roxadustat |
| Outcome Measures: | Primary: Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks, Weeks 1 to 20|Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits, Weeks 17 to 21|Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits, Weeks 33 to 37 | Secondary: Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits, Baseline, Weeks 17 to 21|Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L, Weeks 17 to 21|Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L, Weeks 33 to 37 |
| Sponsor/Collaborators: | Sponsor: FibroGen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 318 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-06-11 |
| Completion Date: | 2021-12-17 |
| Results First Posted: | |
| Last Update Posted: | 2022-05-06 |
| Locations: | Investigational Site, Hefei, Anhui, 230601, China|Investigational Site, Lanzhou, Gansu, 730030, China|Investigational Site, Guangzhou, Guangdong, 510515, China|Investigational Site, Shenzhen, Guangdong, 518020, China|Investigational Site, Nanning, Guangxi Province, 530021, China|Investigational Site, Zhengzhou, Henan, 450052, China|Investigational Site, Wuhan, Hubei, 430060, China|Investigational Site, Changsha, Hunan, 410008, China|Investigational Site, Baotou, Inner Mongolia Autonomous Region, 014010, China|Investigational Site, Nanjing, Jiangsu, 210009, China|Investigational Site, Nanchang, Jiangxi, 330006, China|Investigational Site, Chang chun, Jilin, 130021, China|Investigational Site, Shenyang, Liaoning, 110004, China|Investigational Site, Shenyang, Liaoning, 110122, China|Investigational Site, Taiyuan, Shanxi, 030001, China|Investigational Site, Xi'an, Shanxi, 710004, China|Investigational Site, Xi'an, Shanxi, 710061, China|Investigational Site, Chengdu, Sichuan, 610041, China|Investigational Site, Chengdu, Sichuan, 610072, China|Investigational Site, Hangzhou, Zhejiang, 310003, China|Investigational Site, Beijing, 100044, China|Investigational Site, Beijing, 100191, China|Investigational Site, Beijing, 100730, China|Investigational Site, Shanghai, 200025, China|Investigational Site, Tianjin, 300052, China |
| URL: | https://clinicaltrials.gov/show/NCT04059913 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|