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Clinical Trial Details

Trial ID: L1372
Source ID: NCT02652806
Associated Drug: Fg-4592
Title: FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia
Interventions: DRUG: FG-4592|DRUG: Epoetin Alfa
Outcome Measures: Primary: Hb mean change from baseline, Hb mean change from baseline, Weeks 23 to 27. | Secondary: Mean change from baseline in low-density lipoprotein (LDL) cholesterol, Mean change from baseline in low-density lipoprotein (LDL) cholesterol, Weeks 25-27|Number of subjects with a Hb response, Number of subjects with a Hb response (as defined per protocol), Weeks 23-27|Percent of subjects with a Hb response, Percent of subjects with a Hb response (as defined per protocol), Weeks 23-27|Effect on iron metabolism, Measurement of serum iron, Week 27|Proportion of subjects with exacerbation of hypertension, Proportion of subjects with exacerbation of hypertension, meeting at least one of the following criteria up to Week 27: * Increase in anti-hypertensive medication use, * Adverse event of hypertension, or * Increases from baseline in blood pressure confirmed by repeat measurement at next visit unless anti-hypertensive medications are changed., Up to Week 27|Mean change from baseline in predialysis and postdialysis mean arterial blood pressure, Mean arterial blood pressure measured pre-and post-dialysis., Weeks 23-27|Number of subjects with treatment-emergent adverse events (TEAEs)., Number of subjects with treatment-emergent adverse events (TEAEs)., Week 1 to up to Week 53|Percent of subjects with treatment-emergent adverse events (TEAEs)., Percent of subjects with treatment-emergent adverse events (TEAEs)., Week 1 to up to Week 53|Changes from baseline in vital signs, Measurement of vital signs, Week 1 to up to Week 53|Changes from baseline in ECG findings., ECG recordings., Week 1 to up to Week 53|Changes from baseline in clinical laboratory values., Clinical laboratory values., Week 1 to up to Week 53|Number and % of subjects on rescue therapy during study treatment., Number and % of subjects on rescue therapy during study treatment., Week 1 to up to Week 53|Time to rescue therapy from date of first dose during study treatment., Time to rescue therapy from date of first dose during study treatment., Week 1 to up to Week 53
Sponsor/Collaborators: Sponsor: FibroGen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 305
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date: 2017-06-14
Results First Posted:
Last Update Posted: 2017-08-24
Locations: The Second Hospital of Anhui Medical University, Hefei, Anhui, China|301 Hospital, Beijing, Beijing, China|Peking Union Medical College Hospital, Beijing, Beijing, China|Peking University First Hospital, Beijing, Beijing, China|Peking University Third Hospital, Beijing, Beijing, China|Pekingg University, People's Hospital, Beijing, Beijing, China|The First Affiliated hospital of Third Military Medical University (Southwest Hospital), Chongqing, Chongqing, China|Lan Zhou University Second Hospital, Lanzhou, Gansu, China|Guangdong General Hospital, Guangzhou, Guangdong, China|Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China|Shenzhen People's Hospital, Shenzhen, Guangdong, China|The First Affiliated hospital of Guangxi Medical University, Nanning, Guangxi, China|The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, China|The First Hospital of Baotou Medical School of Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China|Jiangsu Province Hospital, Nanjing, Jiangsu, China|Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu, China|Zhongda Hospital Southeast University, Nanjing, Jiangsu, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China|The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China|Shandong Provincial Hospital, Jinan, Shandong, China|Rui Jin Hospital Shanghai Jiao Tong University School of Medication, Shanghai, Shanghai, 200025, China|Huashan Hospital of Fudan University, Shanghai, Shanghai, 200040, China|Shanghai Changzheng Hospital, Shanghai, Shanghai, China|Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medication, Shanghai, Shanghai, China|The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China|West China Hospital, Sichuan Universtiy, Chengdu, Sichuan, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, China|The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China|Ningbo No.2 Hospital, Ningbo, Zhejiang, China
URL: https://clinicaltrials.gov/show/NCT02652806