Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

NCT02947438 | Completed Phase 3 DMC

• 1 other identifier: SSS_EP_002
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Renal Anemia

Keywords

Renal anemia; Haemodialysis; Maintenance phase

Outcome Measures

Primary Outcomes (2)

• 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).

  from baseline to 6 months

• 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).

  from baseline to 6 months

Secondary Outcomes (4)

• Mean absolute change in haemoglobin level from baseline to 9 months

  from baseline to 9 months

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

  from baseline to 9 months

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

  weeks 32-36

• Incidence of blood transfusions

  52 weak

Other Outcomes (4)

• Incidence and nature of adverse events

  52 weak

• Incidence of drug related adverse events

  52 weak

• Number of subjects who prematurely withdrew from the study due to AE and SAE

  52 weak

Study Arms (2)

Reference group

ACTIVE COMPARATOR

Generic 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.

Drug: EPREX®

Experimental group

EXPERIMENTAL

Generic 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.

Drug: EPIAO®

Interventions

EPREX® DRUG

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.

Also known as: Recombinant human erythropoietin

Reference group

EPIAO® DRUG

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.

Also known as: Recombinant human erythropoietin

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead
• Navitas Life Sciences GmbH: collaborator

Study Sites (19)

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

Volzhsky, Volgograd Oblast, 404120, Russia

Location

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, Russia

Location

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

Moscow, 185019, Russia

Location

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

Orenburg, 460040, Russia

Location

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, Russia

Location

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, Russia

Location

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

Saint Petersburg, 191104, Russia

Location

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

Saint Petersburg, 192242, Russia

Location

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

Saint Petersburg, 195427, Russia

Location

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

Saint Petersburg, 198205, Russia

Location

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

Samara, 443099, Russia

Location

Bamrasnaradura Infectious Disease Institute

Bangkok, 10700, Thailand

Location

Bhumibol Adulyadej hospital

Bangkok, 10700, Thailand

Location

BMA hospital

Bangkok, 10700, Thailand

Location

Chulalongkorn King Memorial hospital

Bangkok, 10700, Thailand

Location

Klongton Hospital

Bangkok, 10700, Thailand

Location

Phramongkutklao hospital

Bangkok, 10700, Thailand

Location

Rajavithi hospital

Bangkok, 10700, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 36451454 DERIVED

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Bolong Miao, Doctoral

  Shenyang Sunshine Pharmaceutical Co., LTD.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 27, 2016
• Study Start: December 1, 2015
• Primary Completion: October 9, 2021
• Study Completion: October 9, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11); TH (8)