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AnemiaPhase 3NCT02652819

FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

A Phase 3 study testing FG-4592 in people with Anemia, run by Kyntra Bio at 30 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, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
30 sitesChina
Study dates
Dec 2015to 13 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.
  • Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.
  • No use of an erythropoiesis-stimulating agent (ESA) for at least 5 weeks before randomization.
  • Mean of the two most recent Hb values during the Screening Period obtained at least 6 days apart must be ≥7.0 g/dL and <10 g/dL.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit (based on central laboratory results).
  • Body weight: 40 to 100 kg inclusive.
  • Subjects agreeing 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 without approval of the FibroGen China Medical Monitor.

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

30 sites in 1 country.

30 sites in 1 country

China30 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

  • 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

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medication

    Shanghai, Shanghai Municipality

  • 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, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.

Read the detailed description

This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis.

Eligible subjects are randomized to FG-4592 or placebo at a ratio of 2:1. The primary endpoint is change in Hb from baseline to the average level during Weeks 7 to 9 inclusive.

Conditions
Anemia
Being tested
FG-4592, Placebo
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

  • PlaceboDrug

Study groups in NCT02652819
Study groupRoleWhat they receive
FG-4592ExperimentalIntervention is investigational treatment FG-4592
Receives: Drug: FG-4592
PlaceboPlacebo comparatorDouble blinded placebo control
Receives: Drug: Placebo

What is being measured

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

  1. Change in Hb from baseline to the average level

    Change in Hb from baseline to the average level

    Measured: Weeks 7 to 9 inclusive.

Secondary outcomes (15)

  1. The proportion of subjects who achieve a confirmed Hb response

    The proportion of subjects who achieve a confirmed Hb response

    Measured: up to and including Week 9

  2. Proportion of subjects with mean Hb ≥10.0 g/dL

    Proportion of subjects with mean Hb ≥10.0 g/dL

    Measured: Weeks 7 to 9

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

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

    Measured: Weeks 7 to 9

  4. Effect on iron metabolism

    Measurement of serum iron

    Measured: Week 9

  5. Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35

    Survey (SF-36) Physical Functioning (PF) subscore measured in Week 9 in the Full Analysis Set (FAS) subjects with baseline PF subscore below 35

    Measured: Week 9

  6. Mean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50.

    Mean change from baseline in SF-36 vitality subscore measured in Week 9 in FAS subjects with baseline vitality subscore below 50.

    Measured: Week 9

  7. Mean change from baseline in mean arterial blood pressure

    Mean change from baseline in mean arterial blood pressure

    Measured: Weeks 7 to 9

  8. Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron)

    Proportion of subjects who received rescue therapy (composite of blood transfusion, ESA use, and IV iron)

    Measured: Up to Week 9

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

    Percent of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)

    Measured: Week 1 up to Week 53

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

    Number of subjects with treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)

    Measured: Week 1 up to Week 53

  11. Changes from baseline in vital signs

    Measurement of vital signs

    Measured: Week 1 up to Week 53

  12. Changes from baseline in ECG findings

    ECG recordings

    Measured: Week 1 up to Week 53

  13. Changes from baseline in clinical laboratory values

    Clinical laboratory values

    Measured: Week 1 up to Week 53

  14. Proportion of subjects on rescue therapy

    Proportion of subjects on rescue therapy

    Measured: Week 1 up to Week 53

  15. Time to rescue therapy from date of first dose

    Time to rescue therapy from date of first dose

    Measured: Week 1 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 completion13 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652819
Sponsor's protocol ID
FGCL-4592-808
Status last verified
Aug 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, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.

    PubMed 31340089

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FG-4592 in people with Anemia, run by Kyntra Bio at 30 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 8 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 30 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. Some participants in this study may receive a placebo. 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?

Change in Hb from baseline to the average level (time frame: Weeks 7 to 9 inclusive.). 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 NCT02652819, 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.

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