Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

NCT ID: NCT02947438

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2021-10-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reference group

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.

Group Type: ACTIVE_COMPARATOR

EPREX®

Intervention Type: 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.

Experimental group

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.

Group Type: EXPERIMENTAL

EPIAO®

Intervention Type: 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.

Interventions

EPREX®

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.

Intervention Type: DRUG

EPIAO®

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.

Intervention Type: DRUG

Other Intervention Names

Recombinant human erythropoietin; Recombinant human erythropoietin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navitas Life Sciences GmbH

INDUSTRY

Sponsor Role: collaborator

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bolong Miao, Doctoral

Role: STUDY_DIRECTOR

Shenyang Sunshine Pharmaceutical Co., LTD.

Locations

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

Volzhsky, Volgograd Oblast, Russia

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, , Russia

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

Moscow, , Russia

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

Orenburg, , Russia

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, , Russia

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, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Samara, , Russia

Bamrasnaradura Infectious Disease Institute

Bangkok, , Thailand

Bhumibol Adulyadej hospital

Bangkok, , Thailand

BMA hospital

Bangkok, , Thailand

Chulalongkorn King Memorial hospital

Bangkok, , Thailand

Klongton Hospital

Bangkok, , Thailand

Phramongkutklao hospital

Bangkok, , Thailand

Rajavithi hospital

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Countries

Russia; Thailand

References

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.

Reference Type: DERIVED

PMID: 36451454 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

SSS_EP_002

Identifier Type: -

Identifier Source: org_study_id