Chronic Kidney DiseasePhase 3NCT02506868

Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

A Phase 3 study testing Darbepoetin alfa in people with Chronic Kidney Disease and End Stage Renal Failure on Dialysis, run by Biocad at 30 sites in Russia.

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

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage 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: Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
What is being tested?: Darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 30 sitesRussia
Study dates: 8 Aug 2015to 21 Dec 2017
Phase: Phase 3
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

Written informed consent
Age between 18 and 75 years
End-stage kidney disease
Need for dialysis for at least 3 months before enrollment
Need for at least 12 hours on standard dialysis procedure weekly
Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) for at least 3 months before enrollment

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Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment
Effective dialysis (Kt/v≥1,2)
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 (according to Investigator's assessment)

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
Hemoglobin above 120 g/l or below 100 g/l
Scheduled kidney transplant during study participation period
Binding/neutralizing antibodies against erythropoetin/darbepoetin

Show all 31Show fewer

History of severe allergic reactions
Vaccination less than 8 weeks before enrollment
Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis
HIV infection, active HBV, HCV
ALT, AST level above 3x ULN
Bone marrow fibrosis
Congestive heart failure (Grade IV NYHA)
Resistant arterial hypertension
Unstable angina
Hemoglobinopathy, MDS, hematologic malignancy
PRCA
Severe secondary hyperparathyroidism (PTH > 9x ULN)
GI bleeding history
Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6 months before enrollment
Acute hemolysis history
Seizures, including epilepsy
Major surgery in less than 1 month before enrollment
Blood transfusions in less than 3 months before enrollment
Acute inflammatory diseases or exacerbations of chronic inflammation including septic of aseptic inflammation foci
Severe psychiatric disorders
History of malignancy, excluding appropriately treated basal cell carcinoma or cervical carcinoma in situ
Alcohol or drug abuse
Hypersensitivity to darbepoetin alfa of any components of study drugs
Simultaneous participation in other trials or in less than 3 months before enrollment
Pregnancy of breast-feeding

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Russia30 sites

St. Josaphat Belgorod Regional Clinical Hospital
Belgorod
Alyans Biomedical - Ural'skaya gruppa
Izhevsk
Kaluga Region Hospital
Kaluga
Kazan State Medical University
Kazan'
Fresenius Medical Care Kuban
Krasnodar
NEFROS Ltd, Medical Centre
Krasnodar
Centr Dializa Ltd
Moscow
City Clinical Hospital #24
Moscow
Federal State Budgetary Institution "Academician V.I.Shumakov Federal Research Center of Transplantology and Artificial Organs", Ministry of Health of the Russian Federation
Moscow
N.I.Pirogov City Clinical Hospital #1
Moscow
Scientific Clinical Centre, JSC Russian Railways
Moscow
Nefrolayn-Novosibirsk Ltd
Novosibirsk
Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation, Urology and Interventional Radiology Research Institute
Obninsk, 249036
A.N. Kabanov City Clinical Hospital #1
Omsk
Omsk Regional Clinical Hospital
Omsk
V.A. Baranov Republican Hospital of Ministry of Health republic Karelia
Petrozavodsk, 185000
City Mariin Hospital
Saint Petersburg, 194104
B.Braun Avitum Russland Clinics Ltd.
Saint Petersburg
Centr Dializa Sankt-Peterburg Ltd
Saint Petersburg
City Hospital #15
Saint Petersburg
City Hospital #40, Kurortny district
Saint Petersburg
Nikolaevskaya Hospital
Saint Petersburg
North-Western State Medical University named after I.I Mechnikov under the Ministry of Public Health of the Russian Federation
Saint Petersburg
St.Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg
State Healthcare Institution Holy Great Martyr Elizabeth City Hospital #2
Saint Petersburg
Regional Clinical Hospital, Saratov
Saratov
Smolensk Regional Clinical Hospital
Smolensk
Tula Regional Hospital
Tula, 300053
Fresenius Nephrocare Ltd - Dialysis Centre #2, Ul'yanovsk
Ulyanovsk
State Healthcare Institution Volgograd Region Uronephrology Centre
Volgograd

Other trials in Russia

About this study

Official title: Multicenter Double-blind Randomized Parallel Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B.V., Netherlands) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.

Read the detailed description

In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).

Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).

Conditions: Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
Being tested: Darbepoetin alfa
Keywords: darbepoetin alfa
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

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

Darbepoetin alfaDrug
Also called Aranesp, BCD-066
Weekly sc administration of darbepoetin alfa

Study groups in NCT02506868
Study group	Role	What they receive
BCD-066	Experimental	Patients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Receives: Drug: Darbepoetin alfa
Aranesp	Active comparator	Patients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks Receives: Drug: Darbepoetin alfa

What is being measured

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

Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
Measured: Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 24

Secondary outcomes (15)

Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period
Hb concentration between 100 and 120 g/l will be considered as target
Measured: Weeks 21 to 24
Mean Darbepoetin Alfa Dose During Evaluation Period
The outcome includes the mean weekly dose of Darbepoetin Alfa which was administered to the patients during the period from week 21 to week 24 (last 4 weeks of the main period of the study)
Measured: Week 21 to Week 24
Number or Percentage of Patients With Need for Blood Transfusions
Measured: Weeks 1 to 24
Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study
Measured: Weeks 1 to 20
Mean Hemoglobin Level During Evaluation Period
The outcome includes the mean hemoglobin level which was registered in the patients during the last 4 weeks of the main period of the study (period from week 21 to week 24)
Measured: Week 24
Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l
Measured: Weeks 21 to 24
Hemoglobin Level Dynamics
Measured: Weeks 1 to 24
Mean Darbepoetin Alfa Dose During the Whole Study
The outcome includes the mean Darbepoetin Alfa Dose During the Whole Study
Measured: Week 24
Mean Hemoglobin Level During the Whole Study (24 Week)
The outcome includes the measuere of Mean Hemoglobin Level During the Whole Study (during the study period from week 1 to week 24 week)
Measured: Week 24
Mean Hematocrit Level During the Whole Study
Measured: Week 24
Number of Patients With AE/SAE (AE/SAE Incidence)
Measured: Weeks 1 to 52
Number of Participants With Grade 3-4 AE/SAE
Measured: Weeks 1 to 52
Number of Participants Who Withdrew From Study Due to AE/SAE
Measured: Weeks 1 to 52
Number of Participants With Arterial and Venous Thrombotic Events
Measured: Weeks 1 to 52
Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa
Measured: Weeks 1 to 52

Timeline

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

8 Aug 201521 Dec 2017

First posted23 Jul 2015 (estimated)
Study start8 Aug 2015
Primary completion8 Jan 2017
Study completion21 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02506868
Sponsor's protocol ID: BCD-066-2
Status last verified: Apr 2020
First submitted: 22 Jul 2015
Last updated: 7 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Double-blind Randomized Parallel Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B.V., Netherlands) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
ClinicalTrials.gov ID: NCT02506868
Acronym / sponsor ID: BCD-066-2
Conditions: Chronic Kidney Disease, End Stage Renal Failure on Dialysis, Anemia
Keywords: darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: 8 Aug 2015 (actual)
Primary completion: 8 Jan 2017 (actual)
Study completion: 21 Dec 2017 (actual)
First posted: 23 Jul 2015 (estimated)
Results: Posted 30 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.

Detailed description

Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BCD-066	Experimental	Drug: Darbepoetin alfaPatients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks
Aranesp	Active comparator	Drug: Darbepoetin alfaPatients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Written informed consent
Age between 18 and 75 years
End-stage kidney disease
Need for dialysis for at least 3 months before enrollment
Need for at least 12 hours on standard dialysis procedure weekly

Key exclusion criteria (31 listed)

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
Hemoglobin above 120 g/l or below 100 g/l
Scheduled kidney transplant during study participation period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Darbepoetin alfaAlso: Aranesp, BCD-066Weekly sc administration of darbepoetin alfa	Drug	Aranesp, BCD-066

Primary outcome

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 24

15 secondary outcomes

Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period
Time frame: Weeks 21 to 24
Mean Darbepoetin Alfa Dose During Evaluation Period
Time frame: Week 21 to Week 24
Number or Percentage of Patients With Need for Blood Transfusions
Time frame: Weeks 1 to 24
Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study
Time frame: Weeks 1 to 20
Mean Hemoglobin Level During Evaluation Period
Time frame: Week 24
Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l
Time frame: Weeks 21 to 24
Hemoglobin Level Dynamics
Time frame: Weeks 1 to 24
Mean Darbepoetin Alfa Dose During the Whole Study
Time frame: Week 24
Mean Hemoglobin Level During the Whole Study (24 Week)
Time frame: Week 24
Mean Hematocrit Level During the Whole Study
Time frame: Week 24
Number of Patients With AE/SAE (AE/SAE Incidence)
Time frame: Weeks 1 to 52
Number of Participants With Grade 3-4 AE/SAE
Time frame: Weeks 1 to 52
Number of Participants Who Withdrew From Study Due to AE/SAE
Time frame: Weeks 1 to 52
Number of Participants With Arterial and Venous Thrombotic Events
Time frame: Weeks 1 to 52
Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa
Time frame: Weeks 1 to 52

Results and safety

Results posted to the registry on 30 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BCD-066	98	86
Aranesp	98	90

Primary outcome: 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 24. Geometric mean (Standard Deviation). Unit: gram per liter

Measure	BCD-066 n = 86	Aranesp n = 90
Value	4.695 (10.941)	4.641 (8.987)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: adverse event were collected during 1 year (24 weeks of main and 28 weeks of additional periods of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCD-066	19 of 98 (19.4%)	84 of 98 (85.7%)	5 of 98
Aranesp	13 of 97 (13.4%)	84 of 97 (86.6%)	4 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrey Biryulin, MD study director

Biocad

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darbepoetin alfa in people with Chronic Kidney Disease and End Stage Renal Failure on Dialysis, run by Biocad at 30 sites in Russia.

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 11 inclusion and 31 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Russia. 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?

Yes. Results are posted in the registry (first posted 30 May 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 24). 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 NCT02506868.

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 7 May 2020.