- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596855
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
January 31, 2013 updated by: FibroGen
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
- Peking University First Hospital
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Beijing, China
- Peking Union Medical College Hospital
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Guangzhou, China
- First Affiliated Hospital, Sun Yat-Sen University
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Hangzhou, China
- Zhejiang University No 1. Hospital
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Shanghai, China
- Ruijin Hospital
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Shanghai, China
- Renji Hospital
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Shanghai, China
- Xinhua Hospital
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Shanghai, China
- Chang Zheng Hospital
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Shenzhen, China
- Shenzhen people's hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FG-4592
Active Drug
|
TIW dosing, capsule
|
Active Comparator: Epoetin alfa
Standard of care
|
TIW
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 7
|
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
|
Week 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
April 30, 2012
First Submitted That Met QC Criteria
May 9, 2012
First Posted (Estimate)
May 11, 2012
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
January 31, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FGCL-4592-048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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