AzTrials
AzTrials

Anaemia Associated With Chronic Kidney DiseasePhase 3NCT04155125

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

A Phase 3 study testing efepoetin alfa and Mircera in people with Anaemia Associated With Chronic Kidney Disease, run by PT Kalbe Genexine Biologics at 55 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
efepoetin alfa and Mircera
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
391 participants
Where
55 sitesin 7 countries
Study dates
2 Jul 2020to 30 Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age should be greater than or equal to the minimum age of consent in the applicable country
  • Stage 3 or 4 CKD (eGFR ≥ 15 and < 60 mL/min/1.73 m2)
  • ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and < 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
  • Ferritin ≥ 100 ng/mL and transferrin saturation (TSAT) ≥ 20%
  • Subject must be willing to complete all study-related activities and follow-up visits
  • Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Who cannot join

  • Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of >20% within 12 weeks)
  • Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
  • Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
  • Have an unstable Hb for any reason, in the investigator's opinion
  • Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
  • Platelet count of ≤ 50 x109/L
Show all 27Show fewer
  • Vitamin B12 deficiency defined as total serum levels of < 181 pmol/L (246 pg/ml) 10
  • Folic acid deficiency defined as total serum levels < 7.63 nmol/L (3.37 ng/mL) 10
  • Pure red cell aplasia, or a history of pure red cell aplasia
  • Poorly controlled hypertension defined as a sitting SBP ≥170 mmHg and/or DBP ≥100 mm Hg
  • Chronic congestive heart failure (New York Heart Association class IV) or are otherwise at high risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before screening or during screening
  • Active or not active malignancy (except non-melanoma skin cancer) within five years before screening
  • Planned live kidney transplantation scheduled within 52 weeks after the screening visit
  • Uncontrolled hyperparathyroidism, in the investigator's opinion
  • Uncontrolled hypothyroidism determined by the investigator that they cannot participate in the study
  • Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus), or a C-reactive protein level > 15 mg/L. (Routinely screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection is not required in this protocol. By history or current clinical evidence, patients with active acute HBV or HCV infection should be excluded. Chronic HBV/HCV infection with LFTs > 3 times of normal are excluded. Known HIV positive patients are excluded)
  • Immunosuppressive therapy (other than corticosteroids for a chronic condition, or tacrolimus/cyclosporine) within 12 weeks prior to baseline
  • Life expectancy of less than 52 weeks
  • Planned surgery during the study period (excluding minor skin excisions)
  • Have received investigational drug(s) other than those of this study within 4 weeks prior to screening, or will receive investigational drug(s) other than those of this study during the study period
  • History or clinical evidence of cardiovascular, haematologic or hepatic (ALT, AST, bilirubin values above three times the upper limit of normal [ULN] at screening) or any physical conditions that, in the opinion of the investigator, would compromise participation in the study
  • With a cognitive or psychiatric condition rendering the subject unable to be cooperative with and complete study requirements
  • Hypersensitivity to any one of the investigational drugs
  • Subjects are, in the judgement of the investigator, otherwise inappropriate for entry into the study
  • Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are KGBio or CRO employees directly involved in the conduct of the trial
  • Participation in other studies involving same investigational drug(s) (Phases 1-4) of this study within 12 weeks before screening
  • Females of childbearing potential or males who are unable/unwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 28 days after last dose of investigational product. Females have a positive pregnancy test result within 24 hours prior to study entry, is otherwise known to be pregnant, plans to become pregnant in the next 12 months or is currently breastfeeding.

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

Taiwan15 sites

  • Changhua Christian Hospital

    Changhua, 100

  • Hualien Tzu Chi Hospital

    Hualien City, 970

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Kaohsiung Chang Gung Hospital

    Kaohsiung City, 83301

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204

  • Taiching Veterans General Hospital

    Taichung, 40705

  • Kuang Tien General Hospital

    Taichung, 433

  • Chi Mei Medical Center

    Tainan, 433

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Tri-Service General Hospital

    Taipei, 114

  • Far Eastern Memorial Hospital

    Taipei, 220

  • Taipei Medical University - Shuang Ho Hospital

    Taipei, 235

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 833

Other trials in Taiwan

Malaysia9 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

  • Hospital Kajang

    Kajang, 43000

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, 15200

  • University of Malaya Medical Centre

    Kuala Lumpur, Selangor, 59100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Serdang

    Serdang, 43000

  • Seri Manjung Hospital

    Seri Manjung, Perak, 32040

  • Hospital Sibu

    Sibu, 96000

Other trials in Malaysia

South Korea9 sites

  • Chungnam National University Hospital

    Daejeon

  • Korea University Ansan Hospital

    Gyeonggi-do

  • Seoul National University Bundang Hospital

    Gyeonggi-do

  • The Catholic University of Korea Incheon St. Mary'S Hospital

    Incheon

  • Chungnam National University Sejong Hospital

    Sejong

  • Kyung Hee University Hospital At Gangdong

    Seoul

  • The Catholic University of Korea Eunpyeong St. Mary'S Hospital

    Seoul

  • The Catholic University of Korea Seoul St. Mary'S Hospital

    Seoul

  • The Catholic University of Korea, Yeouido St. Mary'S Hospital

    Seoul

Other trials in South Korea

Philippines7 sites

  • M3 Dialysis Center

    Bacolod City, 6100

  • Baguio General Hospital Medical Center

    Baguio City, 2600

  • Norzel Medical and Diagnostic Clinic

    Cebu City, 6000

  • De La Salle Medical and Health Sciences Institute

    Dasmariñas, 4114

  • Davao Doctors Hospital

    Davao City, 8000

  • West Visayas State University Hospital

    Iloilo City, 5000

  • National Kidney and Transplant Institute

    Quezon, 1101

Other trials in Philippines

Indonesia6 sites

  • Rspad Gatot Soebroto

    Jakarta Pusat

  • Rumah Sakit Islam Jakarta Cempaka Putih

    Jakarta Pusat

  • Rumah Sakit Islam Jakarta Pondok Kopi

    Jakarta Pusat

  • Rumah Sakit Pgi Cikini

    Jakarta Pusat

  • Rumah Sakit Umum Pusat Fatmawati

    Jakarta Pusat

  • Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo

    Jakarta Pusat

Other trials in Indonesia

Thailand6 sites

  • Vajira Hospital

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Thammasat University Hospital

    Pathum Thani, 12120

  • Songklanagarind Hospital

    Songkhla, 90110

  • Sunpasitthiprasong Hospital

    Ubon Ratchathani, 34000

Other trials in Thailand

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Renal Research Gosford

    Gosford, New South Wales, 2250

  • Launceston General Hospital

    Launceston, Tasmania, 7250

Other trials in Australia

About this study

Official title: Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.

Read the detailed description

The study will consist of a 20-week correction period for dosage titration and Hb correction, followed by an 8-week evaluation period for efficacy assessments of corrective treatment. Subjects who respond to efepoetin alfa (defined as an increase in Hb ≥1.0 g/dL versus baseline and Hb level within 10 - 12 g/dL range without blood transfusion during the 28 weeks after the first dose) will be eligible to continue treatment, and will be randomised to receive subcutaneous efepoetin alfa either once every 2W or every 4W for an additional 24-week extension period to assess long-term safety and maintenance effect. Mircera responders will also be allowed to continue the drug during the extension period, receiving it every 4 weeks using the dose equal to twice the previous once-every-two-week dose. The safety data collected will be part of an ongoing pooled analysis of safety data from the efepoetin alfa clinical development program.

Being tested
efepoetin alfa, Mircera

What participants receive

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

  • efepoetin alfaDrug

    The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.

  • MirceraDrug

    The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.

Study groups in NCT04155125
Study groupRoleWhat they receive
efepoetin alfaExperimentalRoute of administration: Subcutaneous Injection. The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.
Receives: Drug: efepoetin alfa
MirceraPlacebo comparatorRoute of administration: Subcutaneous Injection. The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.
Receives: Drug: Mircera

What is being measured

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

  1. To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period

    Measurement is done by an increase in Hb more than or equal to 1 g/dL compared with baseline and a Hb concentration within range of 10 - 12 g/dL inclusive without transfusion during evaluation period

    Measured: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.

Secondary outcomes (1)

  1. Characterise safety and tolerability of subcutaneous efepoetin alfa is being measured by based on the frequency of adverse events and on the number of out of range laboratory values.

    Safety endpoints parameters including Serious Adverse Events (SAE) specified below

    1. Composite outcome of cardiovascular death or a nonfatal myocardial infarction or stroke
    2. All-cause mortality
    3. Cardiovascular mortality
    4. Acute myocardial infarction
    5. Heart failure
    6. Acute kidney injury defined according to Acute Kidney Injury Network (AKIN) criteria
    7. Abnormal clinical laboratory tests (haematology, biochemistry including serum ferritin and TSAT)
    8. Anti-efepoetin alfa or anti-Mircera antibody titres
    9. Clinically meaningful abnormal findings of vital signs
    10. Development of clinically meaningful electrocardiogram abnormalities
    11. Hospitalisations (excluding those for logistic reasons)

    It is a composite outcome. Any abnormal test findings during the study will be helpful in reviewing the outcome.

    Measured: Measurement from the time the subject provides informed consent through and including 28 calendar days after the last study drug administration.

Timeline

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

  1. First posted7 Nov 2019
  2. Study start2 Jul 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Jun 2023

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
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155125
Sponsor's protocol ID
GXE4KGBio-001
Status last verified
Dec 2023
First submitted
29 Oct 2019
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing efepoetin alfa and Mircera in people with Anaemia Associated With Chronic Kidney Disease, run by PT Kalbe Genexine Biologics at 55 sites in 7 countries.

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 6 inclusion and 27 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Taiwan, Malaysia, South Korea, Philippines, Indonesia and 2 more countries. 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?

To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period (time frame: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.). 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 NCT04155125.

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 22 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in