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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
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia in Chronic Kidney Disease focused on measuring Anemia, Renal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 to 75 years
  2. Subject has voluntarily signed and dated an informed consent form
  3. Chronic Kidney Disease, not receiving dialysis
  4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL
  5. Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period
  6. 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
  7. Total bilirubin values must be ≤ULN during screening period
  8. Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
  9. Body weight: 40 to 100 kg (dry weight) inclusive
  10. Body mass index (BMI): 16 to 38 kg/m2 inclusive

Exclusion Criteria:

  1. Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1
  2. 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,
  3. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
  4. History of chronic liver disease
  5. New York Heart Association Class III or IV congestive heart failure
  6. 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
  7. Active or chronic gastrointestinal bleeding, or a known coagulation disorder
  8. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
  9. Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
  10. History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
  11. Active hemolysis or diagnosis of hemolytic syndrome
  12. Known bone marrow fibrosis
  13. Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)
  14. Any prior organ transplantation
  15. Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
  16. Serum albumin <3 g/dL
  17. History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
  18. Prior treatment with FG-4592
  19. Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.
  20. 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

First Posted
May 11, 2012
Last Updated
February 27, 2014
Sponsor
FibroGen
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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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