FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis
1 other identifier
interventional
154
1 country
30
Brief Summary
This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2015
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 31, 2015
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2017
CompletedAugust 24, 2017
August 1, 2017
1.2 years
December 31, 2015
August 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hb from baseline to the average level
Change in Hb from baseline to the average level
Weeks 7 to 9 inclusive.
Secondary Outcomes (15)
The proportion of subjects who achieve a confirmed Hb response
up to and including Week 9
Proportion of subjects with mean Hb ≥10.0 g/dL
Weeks 7 to 9
Mean change from baseline in low-density lipoprotein (LDL) cholesterol averaged
Weeks 7 to 9
Effect on iron metabolism
Week 9
Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35
Week 9
- +10 more secondary outcomes
Study Arms (2)
FG-4592
EXPERIMENTALIntervention is investigational treatment FG-4592
Placebo
PLACEBO COMPARATORDouble blinded placebo control
Interventions
Eligibility Criteria
You may qualify if:
- Ages 18 to 75 years
- Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions.
- Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- No use of an erythropoiesis-stimulating agent (ESA) for at least 5 weeks before randomization.
- Mean of the two most recent Hb values during the Screening Period obtained at least 6 days apart must be ≥7.0 g/dL and \<10 g/dL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit (based on central laboratory results).
- Body weight: 40 to 100 kg inclusive.
- Subjects agreeing not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period without approval of the FibroGen China Medical Monitor.
You may not qualify if:
- Any clinically significant infection or evidence of an active underlying infection.
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- Chronic liver disease.
- New York Heart Association Class III or IV congestive heart failure.
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1.
- Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization).
- Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound.
- History of malignancy except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease).
- Clinically significant gastrointestinal bleeding.
- Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
- Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
- Anticipated elective surgery that could lead to significant blood loss during the study period.
- Anticipated use of dapsone or acetaminophen (paracetamol) \>2.0 g/day, or \>500 mg per dose repeated every 6 hours for more than 3 days.
- Serum albumin \<2.5 g/dL.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (30)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
301 Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Pekingg University, People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated hospital of Third Military Medical University (Southwest Hospital)
Chongqing, Chongqing Municipality, 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
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medication
Shanghai, Shanghai Municipality, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medication
Shanghai, Shanghai Municipality, 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 Municipality, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Related Publications (2)
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PMID: 36005278DERIVEDChen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.
PMID: 31340089DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2015
First Posted
January 12, 2016
Study Start
December 1, 2015
Primary Completion
January 24, 2017
Study Completion
June 13, 2017
Last Updated
August 24, 2017
Record last verified: 2017-08