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Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China

Primary Purpose

Anemia in End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FG-4592
Epoetin Alfa
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia in End Stage Renal Disease focused on measuring Anemia, Renal

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject has voluntarily signed and dated an informed consent form
  2. Age 18 to 75 years
  3. End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1
  4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.

  5. Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:

    • Epoetin alfa dose range for 6 weeks prior to Day -7:

      3000 to 20,000 IU/week

    • Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)
  6. Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits
  7. Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
  8. Body weight: 40 to 100 kg (dry weight) inclusive
  9. Body mass index (BMI): 16 to 38 kg/m2 inclusive
  10. HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)

Exclusion Criteria:

  1. Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study
  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. History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
  17. Prior treatment with FG-4592
  18. 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
  • First Affiliated Hospital, Sun Yat-Sen University
  • Zhejiang University No 1. Hospital
  • Chang Zheng Hospital
  • Renji Hospital
  • RuiJin Hospital
  • XinHua Hospital
  • ShenZhen People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FG-4592

Epoetin alfa

Arm Description

Active Drug

Standard of care

Outcomes

Primary Outcome Measures

Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.

Secondary Outcome Measures

Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7.
Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level.

Full Information

First Posted
April 30, 2012
Last Updated
January 31, 2013
Sponsor
FibroGen
Collaborators
Ruijin Hospital, RenJi Hospital, Chang Zheng Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Peking University First Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Zhejiang University, Peking Union Medical College Hospital, Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01596855
Brief Title
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
Official Title
A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 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
Collaborators
Ruijin Hospital, RenJi Hospital, Chang Zheng Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Peking University First Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Zhejiang University, Peking Union Medical College Hospital, Shenzhen People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.
Detailed Description
Dose ranging study with three consecutive dose escalation cohorts. The study objectives are to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in End Stage Renal Disease
Keywords
Anemia, Renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FG-4592
Arm Type
Experimental
Arm Description
Active Drug
Arm Title
Epoetin alfa
Arm Type
Active Comparator
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
FG-4592
Intervention Description
TIW dosing, capsule
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Intervention Description
TIW
Primary Outcome Measure Information:
Title
Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.
Time Frame
Week 7
Secondary Outcome Measure Information:
Title
Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7.
Time Frame
Week 7
Title
Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level.
Time Frame
Week 7

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: Subject has voluntarily signed and dated an informed consent form Age 18 to 75 years End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1 Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL. Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows: Epoetin alfa dose range for 6 weeks prior to Day -7: 3000 to 20,000 IU/week Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period) Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits 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 HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter) Exclusion Criteria: Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study 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 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 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
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
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 End-Stage Renal Disease Receiving Maintenance Hemodialysis in China

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