Study of FG-4592 in Subjects With Chronic Kidney Disease in China
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia
1 other identifier
interventional
91
1 country
13
Brief Summary
The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
13 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, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 3, 2014
February 1, 2014
1.1 years
May 11, 2012
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum change in hemoglobin by Week 9 from baseline
Week 9
Secondary Outcomes (2)
Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9.
Week 9
Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL.
Week 9
Study Arms (2)
FG-4592
EXPERIMENTALActive Drug
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18 to 75 years
- Subject has voluntarily signed and dated an informed consent form
- Chronic Kidney Disease, not receiving dialysis
- Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be \<10g/dL
- Aminotransferase levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period
- Serum alkaline phosphatase (ALP) ≤2x ULN during screening period. Subjects with serum ALP values between 1 x and 2 x ULN may be included only if bone-specific ALP (BSAP) is also elevated \> ULN
- Total bilirubin values must be ≤ULN during screening period
- Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
- Body weight: 40 to 100 kg (dry weight) inclusive
- Body mass index (BMI): 16 to 38 kg/m2 inclusive
You may not qualify if:
- Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1
- Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) \> ULN during screening on two separate occasions,
- Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- New York Heart Association Class III or IV congestive heart failure
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- Active or chronic gastrointestinal bleeding, or a known coagulation disorder
- Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
- Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
- History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
- Active hemolysis or diagnosis of hemolytic syndrome
- Known bone marrow fibrosis
- Uncontrolled or symptomatic secondary hyperparathyroidism (PTH\>600ng/L)
- Any prior organ transplantation
- Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyntra Biolead
Study Sites (13)
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital
Chengdu, China
First affiliated hospital of Dalian medical university
Dalian, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Zhejiang University No 1. Hospital
Hangzhou, China
Chang Zheng Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Renji Hospital
Shanghai, China
RuiJin Hospital
Shanghai, China
XinHua Hospital
Shanghai, China
Shenzhen People's Hospital
Shenzhen, China
Related Publications (1)
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: 36005278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
May 11, 2012
First Posted
May 16, 2012
Study Start
December 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
March 3, 2014
Record last verified: 2014-02