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Renal AnaemiaPhase 4BEAT_001NCT02522975

Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)

A Phase 4 study testing EPIAO® and EPREX® in people with Renal Anaemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 8 sites in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet on haemodialysis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Anaemia
What is being tested?
EPIAO® and EPREX®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
8 sitesThailand
Study dates
Aug 2015to Aug 2019
Phase
Phase 4
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

  • Male and female subjects between the age of 18 to 75 years
  • Subjects with renal anaemia (haemoglobin 7.5 g/dl to 10 g/dl)
  • Subjects who are treatment naïve to epoetin
  • Subjects with chronic kidney disease (CKD) stages* 3 and 4 not yet on dialysis (predialysis)
  • Subjects willing to provide a written informed consent
  • Subjects with serum ferritin ≥ 100 μg/L and/or transferrin saturation ≥ 20%
  • CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.

Who cannot join

  • Subjects with anaemia due to other reasons (that is not renal anaemia)
  • Subjects on dialysis
  • Subjects who have undergone blood transfusion within the last 3 months
  • Subjects with major complication such as severe/chronic infections or bleeding, or aluminum toxicity
  • Subjects with suspected or known PRCA
  • Subjects with a history of aplastic anaemia
Show all 21Show fewer
  • Subjects with uncontrolled diabetes (fasting blood glucose > 240 mg/dl) or uncontrolled hypertension (systolic blood pressure > 180 mm Hg, diastolic blood pressure > 110 mm Hg)
  • Subjects with known hypersensitivity to any of the ingredients of the investigational products, the mammalian cell-derived product or human albumin products
  • Subjects with history of seizure disorder
  • Subjects with hematological disorder (thrombocytopenia, neutropenia, or hemolysis)
  • Subjects with hyperparathyroidism (intact parathyroid hormone > 1000 pg/ml)
  • Subjects with severe liver dysfunction
  • Subjects with congestive heart failure and/or angina (NYHA class III and IV)
  • Subjects with myocardial infarction or stroke in the preceding 6 months of screening
  • Subjects with active malignancy in the previous 5 years
  • Subjects with gastrointestinal bleeding in the past 6 months
  • Subjects with immunosuppressive therapy in the previous 3 months
  • Subjects with Hepatitis B virus (HbsAg), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV) and syphilis
  • Female subjects who are pregnant, breast-feeding,planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e. bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
  • Subjects participating in trials involving erythropoietin in the past 6 months before screening
  • Subjects currently participating or participation in an investigational study within 30 days prior screening

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Thailand8 sites

  • Bamrasnaradura Infectious Disease Institute

    Bangkok, 10700

  • Bhumibol Adulyadej hospital

    Bangkok, 10700

  • BMA hospital

    Bangkok, 10700

  • Chulalongkorn King Memorial hospital

    Bangkok, 10700

  • Klongton Hospital

    Bangkok, 10700

  • Phramongkutklao hospital

    Bangkok, 10700

  • Rajavithi hospital

    Bangkok, 10700

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Prospective, Randomized, Double Blind, Parallel Group Study to Establish the Therapeutic Equivalence of EPIAO® With the Standard Treatment EPREX® in Subjects With Chronic Kidney Disease (CKD) Related Anaemia Not Yet on Dialysis

This study is aimed to comprehensively establish the biosimilarity/bioquivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy,safety and immunogenicity.The targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet on haemodialysis.

Read the detailed description

This is a prospective, randomized, double blind, parallel group two arm study to establish the therapeutic equivalence, safety and tolerability of EPIAO® as compared to EPREX® in the treatment of CKD related anaemia in subjects who are not yet on dialysis (pre-dialysis). A total of 96 subjects will be randomized into two groups in a 1:1ratio. Treatment arm A will receive EPIAO® once a week, subcutaneously for period of 52 weeks and treatment arm B will receive EPREX, weight once a week, subcutaneously for period of 52 weeks.

Conditions
Renal Anaemia
Being tested
EPIAO®, EPREX®
Keywords
biosimilar epoetin, efficacy, safety, immunogenicity, renal anaemia

What participants receive

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

  • EPIAO®Drug

    Also called Recombinant human erythropoietin

    Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.

    Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.

  • EPREX®Drug

    Also called Recombinant human erythropoietin

    Recombinant human erythropoietin falls under the pharmacological class of haematopoietic /anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.

    Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.

Study groups in NCT02522975
Study groupRoleWhat they receive
Reference groupActive comparatorGeneric name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease. Dosage form:Injection Strength:2000IU,3000IU,4000IU Frequency and Dosage:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPREX® will be 60 IU/kg body weight.
Receives: Drug: EPREX®
Experimental groupExperimentalGeneric name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease. Dosage form:Injection Strength:2000IU,3000IU,4000IU Frequency and Dosage:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPIAO® will be 60 IU/kg body weight.
Receives: Drug: EPIAO®

What is being measured

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

  1. Mean absolute change in haemoglobin(Hb)

    Mean absolute change in haemoglobin(Hb) level from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (g/dl),respectively."

    Measured: 24 weeks

Secondary outcomes (3)

  1. Mean absolute change in weekly epoetin dosage

    Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (IU/kg/week).

    Measured: 24 weeks

  2. Frequency of adverse events

    To observe the frequency of adverse events following EPIAO® and EPREX® administration.

    Measured: 52 weeks

  3. Occurence of anti-epoetin antibodies

    To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.

    Measured: 52 weeks

Timeline

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

  1. First posted14 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2019
  4. Study completionAug 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02522975
Sponsor's protocol ID
SSS_EP_001
Acronym
BEAT_001
Status last verified
Oct 2020
First submitted
10 Aug 2015
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EPIAO® and EPREX® in people with Renal Anaemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 8 sites in Thailand.

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 21 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: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early. Results are not available in the source record.

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?

Mean absolute change in haemoglobin(Hb) (time frame: 24 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 NCT02522975.

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 Oct 2020.

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