AzTrials
AzTrials

Renal AnemiaPhase 3BEAT_002NCT02947438

Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

A Phase 3 study testing EPREX® and EPIAO® in people with Renal Anemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 19 sites in 2 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 study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Anemia
What is being tested?
EPREX® and EPIAO®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
19 sitesin 2 countries
Study dates
Dec 2015to 9 Oct 2021
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

  • Male and female subjects between the age of 18 to 75 years
  • Subjects with end stage renal disease (CKD stage 5) on hemodialysis and on epoetin treatment for at least 3 months prior to screening
  • Subjects with haemoglobin between 10 g/dl to 12 g/dl
  • Subjects who are on clinically stable haemodialysis (defined as no clinically relevant changes of dialysis regimen and/or dialyzer) for at least 3 months prior to screening
  • Subjects willing to provide a written informed consent
  • Subjects with serum ferritin ≥ 200 μg/L and/or transferrin saturation ≥ 20%
  • Subjects with a life expectancy of more than at least study period in clinical judgment of the investigator

Who cannot join

  • Subjects with anaemia due to other reasons (that is not renal anaemia)
  • 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 pure red cell aplasia (PRCA)
  • Subjects with a history of aplastic anaemia
  • 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)
Show all 18Show fewer
  • 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
  • Subjects with hyperparathyroidism
  • 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 active hepatitis B virus (HBsAg) (positive for HBsAg and IgM anti-HBc) and hepatitis C virus (HCV) (positive for Anti-HCV antibody) and human immunodeficiency virus (HIV)
  • 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

19 sites in 2 countries.

19 sites in 2 countries

Russia11 sites

  • State budgetary healthcare institution of Moscow region "Moscow Regional Scientific Research and Clinical Institute named after M.F.Vladimirsky", Department of Transplantation, nephrology and surgical hemocorrection

    Moscow, 129110

  • State Budgetary Healthcare Institution of the Republic of Karelia "V.A. Baranov Republican Hospital"

    Moscow, 185019

  • State budgetary healthcare institution "City Clinical Hospital № 1" of Orenburg

    Orenburg, 460040

  • State Budgetary Educational Institution of Higher Professional Education "North-Western State Medical University named after I.I. Mechnikov " Ministry of Health of Russian Federation

    Saint Petersburg, 191015

  • The Federal State Budgetary Institute "The Nikiforov Russian Center of Emergency and Radiation Medicine" of the Ministry of Russian Federation for Civil Defense, Emergencies and Elimination of Consequences of Natural Disasters

    Saint Petersburg, 191015

  • St- Petersburg state budgetary healthcare institution "City Mariinsky Hospital", department of hemodialysis

    Saint Petersburg, 191104

  • State budgetary institution "St-Petersburg' scientific-research institution of emergency n.a Dzanelidze)"

    Saint Petersburg, 192242

  • St-Peterburg State healthcare institution "Municipal hospital of "Elizabethan Hospital

    Saint Petersburg, 195427

  • Saint-Petersburg State Budgetary Healthcare Institution "City Hospital No. 15"

    Saint Petersburg, 198205

  • Federal State Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation

    Samara, 443099

  • State Budgetary Healthcare Institution "Volgogradskiy Regional Center of Urology and Nephrology"

    Volzhsky, Volgograd Oblast, 404120

Other trials in Russia

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 Evaluate a 1:1 Dose Conversion From EPREX to EPIAO in Term of Clinical Efficacy and Safety in Subjects With End-Stage Renal Disease on Haemodialysis

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and 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 on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO® 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.

Conditions
Renal Anemia
Being tested
EPREX®, EPIAO®
Keywords
Renal anemia, Haemodialysis, Maintenance phase

What participants receive

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

  • 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.

  • 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.

Study groups in NCT02947438
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: Intravenously injection 1-3 times a week for a period of 52 weeks.
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: Intravenously injection 1-3 times a week for a period of 52 weeks.
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 level from baseline to 6 months

    Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).

    Measured: from baseline to 6 months

  2. Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months

    Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).

    Measured: from baseline to 6 months

Secondary outcomes (4)

  1. Mean absolute change in haemoglobin level from baseline to 9 months

    Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl).

    Measured: from baseline to 9 months

  2. Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months

    Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).

    Measured: from baseline to 9 months

  3. Proportion of subjects with hemoglobin values are within 10 - 12 g/dl

    Proportion of subjects with hemoglobin values are within 10 - 12 g/dl for the last 4 weeks of the period for assessment of treatment of efficacy and safety (weeks 32-36)

    Measured: weeks 32-36

  4. Incidence of blood transfusions

    Incidence of blood transfusions

    Measured: 52 weak

Timeline

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

  1. First posted27 Oct 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion9 Oct 2021
  4. Study completion9 Oct 2021

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
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947438
Sponsor's protocol ID
SSS_EP_002
Acronym
BEAT_002
Status last verified
Mar 2022
First submitted
26 Oct 2016
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Miao B, Isachkina AN, Shutov EV, Selyutin AA, Kvitkova LV, Shilo VY, Vetchinnikova ON, Alexandrov IV, Perlin DV, Zuev AV, Davydkin IL, Mironova TP, Solovyova OM, Tutin AP, Omelchenko AM, Vareesangthip K, Khadikova NG, Li M, Li X. Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX(R) to EPIAO(R) in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study. Medicine (Baltimore). 2022 Nov 25;101(47):e31426. doi: 10.1097/MD.0000000000031426.

    PubMed 36451454

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EPREX® and EPIAO® in people with Renal Anemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 19 sites in 2 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 7 inclusion and 18 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 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Russia, 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 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?

Mean absolute change in haemoglobin level from baseline to 6 months (time frame: from baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT02947438, which also lists 1 linked publication.

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 23 Nov 2022.

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