FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease

August 23, 2017 updated by: FibroGen

A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis

This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis. Eligible subjects are randomized to FG-4592 or epoetin alfa at a ratio of 2:1. The primary endpoint is Hb mean change from baseline averaged over Weeks 23 to 27.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
305

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • China
    • Anhui
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • 301 Hospital
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Pekingg University, People's Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Third Military Medical University (Southwest Hospital)
    • Gansu
      • Lanzhou, Gansu, China
        • Lan Zhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China
        • Nanfang Hospital, Southern Medical University
      • Shenzhen, Guangdong, China
        • Shenzhen People's Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
      • Nanning, Guangxi, China
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Hunan
      • Changsha, Hunan, China
        • The second Xiangya Hospital of Central South University
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • The First Hospital of Baotou Medical School of Inner Mongolia University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Nanjing General Hospital of Nanjing Military Command
      • Nanjing, Jiangsu, China
        • Zhongda Hospital Southeast University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Dalian, Liaoning, China
        • The First Affiliated Hospital of Dalian Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medication
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital of Fudan University
      • Shanghai, Shanghai, China
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medication
    • Shanxi
      • Taiyuan, Shanxi, China
        • The Second Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan Universtiy
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital, Zhejiang University
      • Ningbo, Zhejiang, China
        • Ningbo No.2 Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 18 to 75 years
  2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions; a separate ICF is needed for subjects participating in the PK Sub-study.
  3. "Chronic kidney disease with end-stage renal disease (ESRD) on either adequate hemodialysis (HD) or adequate peritoneal dialysis for a minimum of 16 weeks prior to Day 1: For subjects undergoing HD, the vascular access must be via native arteriovenous (AV) fistula or graft, or permanent, tunneled catheter."
  4. Subjects must be on stable doses of IV or subcutaneous (SC) injections of epoetin alfa for at least 6 weeks prior to Day 1 (average dose ≤15,000 IU/week)
  5. Mean of the two most recent central laboratory Hb values during the Screening Period, obtained at least 6 days apart, must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of \≤1.5 g/dL between the highest and the lowest Hb values.
  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit except for subjects with Gilberts syndrome (based on central laboratory results).
  7. Body weight: 45 to 100 kg inclusive 8 Subjects agree not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period.

Exclusion Criteria:

  1. Any clinically significant infection or evidence of an active underlying infection.
  2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
  3. Chronic liver disease.
  4. New York Heart Association Class III or IV congestive heart failure.
  5. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1.
  6. Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization).
  7. Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound.
  8. History of malignancy except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
  9. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
  10. Clinically significant gastrointestinal bleeding.
  11. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
  12. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
  13. Anticipated elective surgery that could lead to significant blood loss during the study period.
  14. Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 days.
  15. Serum albumin <2.5 g/dL.
  16. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
  17. Life expectancy of <12 months.
  18. Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion.
  19. IV iron supplement during the Screening Period and /or unwilling to withhold IV iron.
  20. Immune suppressive or systematic steroid treatment within 12 weeks prior to Day 1.
  21. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
  22. Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
  23. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.
  24. Women who are pregnant or breastfeeding.
  25. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
  26. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this study, may confound efficacy or safety assessment, or may interfere with study participation.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FG-4592
Intervention is investigational treatment FG-4592
Drug: FG-4592
Active Comparator: EPO
Intervention is subject's current dose of Li Xue Bao (epoetin alfa)
Drug: Epoetin Alfa
Other Names:
  • Li Xue Bao

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hb mean change from baseline
Time Frame: Weeks 23 to 27.
Hb mean change from baseline
Weeks 23 to 27.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change from baseline in low-density lipoprotein (LDL) cholesterol
Time Frame: Weeks 25-27
Mean change from baseline in low-density lipoprotein (LDL) cholesterol
Weeks 25-27
Number of subjects with a Hb response
Time Frame: Weeks 23-27
Number of subjects with a Hb response (as defined per protocol)
Weeks 23-27
Percent of subjects with a Hb response
Time Frame: Weeks 23-27
Percent of subjects with a Hb response (as defined per protocol)
Weeks 23-27
Effect on iron metabolism
Time Frame: Week 27
Measurement of serum iron
Week 27
Proportion of subjects with exacerbation of hypertension
Time Frame: Up to Week 27

Proportion of subjects with exacerbation of hypertension, meeting at least one of the following criteria up to Week 27:

  • Increase in anti-hypertensive medication use,
  • Adverse event of hypertension, or
  • Increases from baseline in blood pressure confirmed by repeat measurement at next visit unless anti-hypertensive medications are changed.
Up to Week 27
Mean change from baseline in predialysis and postdialysis mean arterial blood pressure
Time Frame: Weeks 23-27
Mean arterial blood pressure measured pre-and post-dialysis.
Weeks 23-27
Number of subjects with treatment-emergent adverse events (TEAEs).
Time Frame: Week 1 to up to Week 53
Number of subjects with treatment-emergent adverse events (TEAEs).
Week 1 to up to Week 53
Percent of subjects with treatment-emergent adverse events (TEAEs).
Time Frame: Week 1 to up to Week 53
Percent of subjects with treatment-emergent adverse events (TEAEs).
Week 1 to up to Week 53
Changes from baseline in vital signs
Time Frame: Week 1 to up to Week 53
Measurement of vital signs
Week 1 to up to Week 53
Changes from baseline in ECG findings.
Time Frame: Week 1 to up to Week 53
ECG recordings.
Week 1 to up to Week 53
Changes from baseline in clinical laboratory values.
Time Frame: Week 1 to up to Week 53
Clinical laboratory values.
Week 1 to up to Week 53
Number and % of subjects on rescue therapy during study treatment.
Time Frame: Week 1 to up to Week 53
Number and % of subjects on rescue therapy during study treatment.
Week 1 to up to Week 53
Time to rescue therapy from date of first dose during study treatment.
Time Frame: Week 1 to up to Week 53
Time to rescue therapy from date of first dose during study treatment.
Week 1 to up to Week 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FibroGen

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FGCL-4592-806

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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