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AnemiaPhase 3NCT02652806

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

A Phase 3 study testing FG-4592 and Epoetin Alfa in people with Anemia, run by Kyntra Bio at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anemia
What is being tested?
FG-4592 and Epoetin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
31 sitesChina
Study dates
Dec 2015to 14 Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18 to 75 years
  • 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.
  • "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."
  • 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)
  • 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.
  • 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).
  • 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.

Who cannot join

  • Any clinically significant infection or evidence of an active underlying infection.
  • Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
  • Chronic liver disease.
  • New York Heart Association Class III or IV congestive heart failure.
  • 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.
  • Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization).
Show all 26Show fewer
  • Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound.
  • 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.
  • Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
  • Clinically significant gastrointestinal bleeding.
  • 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.
  • Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
  • Anticipated elective surgery that could lead to significant blood loss during the study period.
  • 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.
  • Serum albumin <2.5 g/dL.
  • Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.
  • Life expectancy of <12 months.
  • Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion.
  • IV iron supplement during the Screening Period and /or unwilling to withhold IV iron.
  • Immune suppressive or systematic steroid treatment within 12 weeks prior to Day 1.
  • History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
  • Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
  • Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.
  • Women who are pregnant or breastfeeding.
  • Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • The First Hospital of Baotou Medical School of Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia

  • 301 Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Pekingg University, People's Hospital

    Beijing, Beijing Municipality

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan Universtiy

    Chengdu, Sichuan

  • The First Affiliated hospital of Third Military Medical University (Southwest Hospital)

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Lan Zhou University Second Hospital

    Lanzhou, Gansu

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nanjing General Hospital of Nanjing Military Command

    Nanjing, Jiangsu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • The First Affiliated hospital of Guangxi Medical University

    Nanning, Guangxi

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medication

    Shanghai, Shanghai Municipality, 200025

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medication

    Shanghai, Shanghai Municipality

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Anemia
Being tested
FG-4592, Epoetin Alfa
Keywords
Chronic Kidney Disease
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG-4592Drug

  • Epoetin AlfaDrug

    Also called Li Xue Bao

Study groups in NCT02652806
Study groupRoleWhat they receive
FG-4592ExperimentalIntervention is investigational treatment FG-4592
Receives: Drug: FG-4592
EPOActive comparatorIntervention is subject's current dose of Li Xue Bao (epoetin alfa)
Receives: Drug: Epoetin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hb mean change from baseline

    Hb mean change from baseline

    Measured: Weeks 23 to 27.

Secondary outcomes (13)

  1. Mean change from baseline in low-density lipoprotein (LDL) cholesterol

    Mean change from baseline in low-density lipoprotein (LDL) cholesterol

    Measured: Weeks 25-27

  2. Number of subjects with a Hb response

    Number of subjects with a Hb response (as defined per protocol)

    Measured: Weeks 23-27

  3. Percent of subjects with a Hb response

    Percent of subjects with a Hb response (as defined per protocol)

    Measured: Weeks 23-27

  4. Effect on iron metabolism

    Measurement of serum iron

    Measured: Week 27

  5. Proportion of subjects with exacerbation of hypertension

    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.

    Measured: Up to Week 27

  6. Mean change from baseline in predialysis and postdialysis mean arterial blood pressure

    Mean arterial blood pressure measured pre-and post-dialysis.

    Measured: Weeks 23-27

  7. Number of subjects with treatment-emergent adverse events (TEAEs).

    Number of subjects with treatment-emergent adverse events (TEAEs).

    Measured: Week 1 to up to Week 53

  8. Percent of subjects with treatment-emergent adverse events (TEAEs).

    Percent of subjects with treatment-emergent adverse events (TEAEs).

    Measured: Week 1 to up to Week 53

  9. Changes from baseline in vital signs

    Measurement of vital signs

    Measured: Week 1 to up to Week 53

  10. Changes from baseline in ECG findings.

    ECG recordings.

    Measured: Week 1 to up to Week 53

  11. Changes from baseline in clinical laboratory values.

    Clinical laboratory values.

    Measured: Week 1 to up to Week 53

  12. Number and % of subjects on rescue therapy during study treatment.

    Number and % of subjects on rescue therapy during study treatment.

    Measured: Week 1 to up to Week 53

  13. Time to rescue therapy from date of first dose during study treatment.

    Time to rescue therapy from date of first dose during study treatment.

    Measured: Week 1 to up to Week 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion24 Jan 2017
  4. Study completion14 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652806
Sponsor's protocol ID
FGCL-4592-806
Status last verified
Feb 2017
First submitted
31 Dec 2015
Last updated
24 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36005278

  • Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, Liang X, Jiang G, Liu Z, Li X, Zuo L, Luo L, Wang J, Zhao MH, Liu Z, Cai GY, Hao L, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis. N Engl J Med. 2019 Sep 12;381(11):1011-1022. doi: 10.1056/NEJMoa1901713. Epub 2019 Jul 24.

    PubMed 31340116

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FG-4592 and Epoetin Alfa in people with Anemia, run by Kyntra Bio at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hb mean change from baseline (time frame: Weeks 23 to 27.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02652806, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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