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AnemiaPhase 2NCT03519243

Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis

A Phase 2 study testing BCD-131 and Mircera in people with Anemia, run by Biocad at 3 sites in 2 countries.

Completed

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

Official record
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Trial summary

BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anemia
What is being tested?
BCD-131 and Mircera
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
3 sitesin 2 countries
Study dates
24 Oct 2017to 10 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed written informed consent.
  • Men and women aged from 18 to 75 years (inclusive) on the day of signing informed consent;
  • End-stage kidney disease.
  • Need for dialysis for at least 3 months before signing informed consent.
  • Need for at least 12 hours on standard dialysis procedure weekly.
  • rHuEpo (epoetin alpha, epoetin beta, darbepoetin alpha) administration for at least 3 months before signing informed consent.
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  • Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) before signing informed consent.
  • Target hemoglobin level (100-120 g/l) for at least 3 months before signing informed consent.
  • Effective dialysis dose index (Kt/v) ≥1.2 for patients receiving hemodialysis and (Kt/v) ≥1.7 for patients receiving peritoneal dialysis.
  • TSAT ≥20%, Serum ferritin >200 ng/ml.
  • Patients and their sexual partners with childbearing potential must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 4 weeks after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization. Reliable contraceptive measures include two methods of contraception, including one barrier method/
  • Patients should be able to follow the Protocol procedures

Who cannot join

  • Any other causes of anemia except for renal anemia, including folate and B12 deficiency, chronic blood loss, aluminium intoxication, sickle-cell anemia, chronic disease anemia (CRP above 20 mg/l), refractory anemia with blast cells in peripheral blood.
  • Lupus nephritis of kidney disease due to systemic vasculitis.
  • Platelet count below 100х10^9 cells/l.
  • Scheduled kidney transplant during study participation period.
  • Hypersensitivity to darbepoetin alfa or of any components of study drugs, or to Fe (III)-hydroxide-sucrose complex.
  • Vaccination less than 8 weeks before signing informed consent.
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  • Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis.
  • HIV infection, active HBV, HCV.
  • ALT, AST level above 3x ULN.
  • Congestive heart failure (Grade IV NYHA)
  • Resistant arterial hypertension.
  • Unstable angina.
  • Hemoglobinopathy, MDS, hematologic malignancy, PRCA.
  • Severe secondary hyperparathyroidism.
  • Gastrointestinal bleeding history.
  • Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6 months before signing informed consent.
  • Seizures, including epilepsy.
  • Major surgery in less than 1 month before signing informed consent
  • Blood transfusions in less than 3 months before signing informed consent.
  • Acute inflammatory diseases or exacerbations of chronic inflammation.
  • Severe psychiatric disorders and suicidal ideation and suicidal behavior.
  • History of malignancy, excluding appropriately treated basal cell carcinoma or cervical carcinoma in situ.
  • Alcohol or drug abuse.
  • Simultaneous participation in other trials or in less than 3 months before signing informed consent
  • Pregnancy of breast-feeding.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Russia2 sites

  • City Mariin Hospital

    Saint Petersburg, 194104

  • B.Braun Avitum Russland Clinics Ltd.

    Saint Petersburg

Other trials in Russia

Belarus1 site

  • City Clinical Hospital №9

    Minsk

Other trials in Belarus

About this study

Official title: Randomized Open-Label Comparative Study of the Efficacy and Safety of BCD-131 (JSC BIOCAD, Russia) and Mircera (F. Hoffmann-La Roche Ltd, Switzerland) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.

Read the detailed description

The hypothesis of the study is that the efficacy of BCD-131 is equivalent to that of Mircera® based on the analysis of the primary endpoint (changes in the Hb level over the period of evaluation as compared to the baseline Hb level ) during the 21-week period of treatment.

This study is a study of the maintenance treatment of anemia. The study will include up to 100 dialysis patients with stage 5D chronic kidney disease, established efficacy of dialysis and renal anemia without other causes of anemia, receiving erythropoiesis-stimulating agents (ESA) and reaching target hemoglobin levels.

Conditions
Anemia
Being tested
BCD-131, Mircera
Medical subject headings
Anemia

What participants receive

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

  • BCD-131Biological

    Also called pegylated darbepoetin beta

    subcutaneously monthly

  • MirceraBiological

    Also called Methoxy polyethylene glycol-epoetin beta

    subcutaneously monthly

Study groups in NCT03519243
Study groupRoleWhat they receive
BCD-131 1,05 mcg/kg * conversion ratioExperimentalsubcutaneously monthly
Receives: Biological: BCD-131
BCD-131 1,7 mcg/kg * conversion ratioExperimentalsubcutaneously monthly
Receives: Biological: BCD-131
BCD-131 2,75 mcg/kg * conversion ratioExperimentalSubcutaneously monthly
Receives: Biological: BCD-131
MirceraActive comparatorsubcutaneously monthly
Receives: Biological: Mircera

What is being measured

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

  1. Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period

    The baseline hemoglobin will be calculated as the arithmetic mean of hemoglobin values obtained at screening and at Visit 1. The final hemoglobin value during the evaluation period will be calculated as the arithmetic mean of hemoglobin values obtained at Week 21 and Week 23.

    Measured: Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23

Secondary outcomes (7)

  1. The Proportion of Patients Who Developed AEs/SAEs That, in the Investigator's Opinion, Are Related to BCD-131

    The proportion of patients, in each group, who developed СТСАЕ v. 4.03 Grade 3-4 AEs that, in the Investigator's opinion, are related to BCD-131

    • the proportion of patients, in each group, who discontinued the study due to AEs/SAEs

    Measured: Week 23

  2. The Proportion of BAb- and NAb-positive Patients

    Blood sampling for immunogenicity assessment (BAbs and NAbs) will be performed in all the patients included in the study before the first injection and then at Week 9 and Week 23.

    The immunogenicity endpoints will be analyzed after the completion of all periods of the study.

    Measured: Week 9, 23

  3. AUC(0-672 Hour)

    Area under the concentration curve from the moment of injection to 672 h [28 days])

    Measured: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1

  4. AUC(0-∞)

    Area under the concentration curve from the moment of injection to infinity

    Measured: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21

  5. Cmax

    Maximum serum concentration of the drug product) after the first injection of the test/reference drug

    Measured: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21

  6. AUEC(0-672 Hour)

    Area under the effect curve from the drug injection to 672 h [28 days]) based on the change in the absolute reticulocyte count after the first injection of the test/reference drug

    Measured: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1

  7. AC-Emax

    Maximum absolute reticulocyte count after the first injection of BCD-131/Mircera®

    Measured: day 28

Timeline

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

  1. First posted8 May 2018
  2. Study start24 Oct 2017
  3. Primary completion1 Dec 2018
  4. Study completion10 Dec 2018

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03519243
Sponsor's protocol ID
BCD-131-2
Status last verified
Feb 2021
First submitted
26 Apr 2018
Last updated
4 Mar 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCD-131 and Mircera in people with Anemia, run by Biocad at 3 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 12 inclusion and 25 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia, Belarus. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period (time frame: Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23). 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 NCT03519243.

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 4 Mar 2021.

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