Study of FG-4592 in Subjects With Chronic Kidney Disease in China
Primary Purpose
Anemia in Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FG-4592
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia in Chronic Kidney Disease focused on measuring Anemia, Renal
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Serum albumin <3 g/dL
- History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
- Prior treatment with FG-4592
- Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.
- Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
Sites / Locations
- Peking Union Medical College Hospital
- Peking University First Hospital
- Sichuan Provincial People's Hospital
- West China Hospital
- First affiliated hospital of Dalian medical university
- First Affiliated Hospital, Sun Yat-Sen University
- Zhejiang University No 1. Hospital
- Chang Zheng Hospital
- Huashan Hospital
- Renji Hospital
- RuiJin Hospital
- XinHua Hospital
- Shenzhen People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FG-4592
Placebo
Arm Description
Active Drug
Outcomes
Primary Outcome Measures
Maximum change in hemoglobin by Week 9 from baseline
Secondary Outcome Measures
Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9.
Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01599507
Brief Title
Study of FG-4592 in Subjects With Chronic Kidney Disease in China
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Chronic Kidney Disease
Keywords
Anemia, Renal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FG-4592
Arm Type
Experimental
Arm Description
Active Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FG-4592
Intervention Description
TIW dosing, capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TIW dosing, capsule
Primary Outcome Measure Information:
Title
Maximum change in hemoglobin by Week 9 from baseline
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9.
Time Frame
Week 9
Title
Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL.
Time Frame
Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Serum albumin <3 g/dL
History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
Prior treatment with FG-4592
Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.
Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
Country
China
Facility Name
West China Hospital
City
Chengdu
Country
China
Facility Name
First affiliated hospital of Dalian medical university
City
DaLian
Country
China
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
Country
China
Facility Name
Zhejiang University No 1. Hospital
City
Hangzhou
Country
China
Facility Name
Chang Zheng Hospital
City
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
Renji Hospital
City
Shanghai
Country
China
Facility Name
RuiJin Hospital
City
Shanghai
Country
China
Facility Name
XinHua Hospital
City
Shanghai
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36005278
Citation
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.
Results Reference
derived
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Study of FG-4592 in Subjects With Chronic Kidney Disease in China
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