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

This study has been completed.
Sponsor:
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
Zhejiang University No 1. Hospital
Peking Union Medical College Hospital
Shenzhen People's Hospital
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01596855
First received: April 30, 2012
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Anemia in End Stage Renal Disease
Drug: FG-4592
Drug: Epoetin Alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by FibroGen:

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. [ Time Frame: Week 7 ] [ Designated as safety issue: No ]

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. [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592
Active Drug
Drug: FG-4592
TIW dosing, capsule
Active Comparator: Epoetin alfa
Standard of care
Drug: Epoetin Alfa
TIW

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596855

Locations
China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Zhejiang University No 1. Hospital
Hangzhou, China
XinHua Hospital
Shanghai, China
Chang Zheng Hospital
Shanghai, China
Renji Hospital
Shanghai, China
RuiJin Hospital
Shanghai, China
ShenZhen People's Hospital
Shenzhen, China
Sponsors and Collaborators
FibroGen
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
Zhejiang University No 1. Hospital
Peking Union Medical College Hospital
Shenzhen People's Hospital
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01596855     History of Changes
Other Study ID Numbers: FGCL-4592-048
Study First Received: April 30, 2012
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by FibroGen:
Anemia
Renal

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014