Chronic Kidney DiseasePhase 3SENSENCT01576341
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
A Phase 3 study testing HX575 epoetin alfa (Sandoz) in people with Chronic Kidney Disease, run by Sandoz at 50 sites in 7 countries.
Trial summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- HX575 epoetin alfa (Sandoz)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Apr 2012to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Adult male and female patients w or w/o dialysis treatment
- Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
- Adequate iron substitution
Main Exclusion Criteria:
- History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
- Contraindications for ESA therapy
- Serum albumin < 3.0 g/dL
- Immunocompromized patients (immunosuppressive treatment, chemotherapy)
- Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
- Systemic lupus erythematosus
- Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
- History of malignancy of any organ system within the last 5 years
- History of use of any non-EU approved ESA
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
Russia17 sites
Sandoz Investigative Site
Chelyabinsk
Sandoz Investigative Site
Kemerovo
Sandoz Investigative Site
Kolomna
Sandoz Investigative Site
Moscow
Sandoz Investigative Site
Mytischi
Sandoz Investigative Site
Nizhny Novgorod
Sandoz Investigative Site
Novosibirsk
Sandoz Investigative Site
Orenburg
Sandoz Investigative Site
Petrozavodsk
Sandoz Investigative Site
Podolsk
Sandoz Investigative Site
Pyatigorsk
Sandoz Investigative Site
Ryazan
Sandoz Investigative Site
Saint Petersburg
Sandoz Investigative Site
Saratov
Sandoz Investigative Site
Smolensk
Sandoz Investigative Site
Yaroslavl
Sandoz Investigative Site
Yekaterinburg
Ukraine13 sites
Sandoz Investigative Site
Chernivtsi
Sandoz Investigative Site
Dnipropetrovsk
Sandoz Investigative Site
Donetsk
Sandoz Investigative Site
Ivano-Frankivsk
Sandoz Investigative Site
Kharkiv
Sandoz Investigative Site
Kyiv
Sandoz Investigative Site
Luhansk
Sandoz Investigative Site
Mykolayiv
Sandoz Investigative Site
Poltava
Sandoz Investigative Site
Ternopil
Sandoz Investigative Site
Uzhhorod
Sandoz Investigative Site
Zaporizhya
Sandoz Investigative Site
Zhitomyr
Poland8 sites
Sandoz Investigative Site
Częstochowa
Sandoz Investigative Site
Gdansk
Sandoz Investigative Site
Gdynia
Sandoz Investigative Site
Olkusz
Sandoz Investigative Site
Płock
Sandoz Investigative Site
Poznan
Sandoz Investigative Site
Wadowice
Sandoz Investigative Site
Warzawa
Romania5 sites
Sandoz Investigative Site
Bucharest
Sandoz Investigative Site
Constanța
Sandoz Investigative Site
Lasi
Sandoz Investigative Site
Oradea
Sandoz Investigative Site
Timișoara
Germany3 sites
Sandoz Investigative Site
Düsseldorf
Sandoz Investigative Site
Homberg (Efze)
Sandoz Investigative Site
Nettetal
Turkey (Türkiye)3 sites
Sandoz Investigative Site
Adana
Sandoz Investigative Site
Ankara
Sandoz Investigative Site
Istanbul
About this study
Official title: Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
- Conditions
- Chronic Kidney Disease
- Being tested
- HX575 epoetin alfa (Sandoz)
- Keywords
- Epoetin alfa, ESA, HX575, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX575 epoetin alfa (Sandoz)Drug
Also called Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
| Study group | Role | What they receive |
|---|---|---|
| HX575 epoetin alfa (Sandoz) | Experimental | Single arm Receives: Drug: HX575 epoetin alfa (Sandoz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Measured: 52 weeks
Secondary outcomes (1)
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionJun 2015
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz Biopharmaceuticals, Study chair, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576341
- Sponsor's protocol ID
- HX575-308
- Other IDs
- 2011-002871-40
- Acronym
- SENSE
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2012
- Last updated
- 19 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
- ClinicalTrials.gov ID
- NCT01576341
- Acronym / sponsor ID
- SENSE / HX575-308
- Conditions
- Chronic Kidney Disease
- Keywords
- Epoetin alfa, ESA, HX575, CKD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX575 epoetin alfa (Sandoz) | Experimental | Drug: HX575 epoetin alfa (Sandoz)Single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HX575 epoetin alfa (Sandoz)Also: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia. | Drug | HX575 epoetin alfa (Sandoz) |
Primary outcome
Anti-Erythropoietin (EPO) Antibodies
Time frame: 52 weeks
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
1 secondary outcome
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sandoz Biopharmaceuticals study chair
Sandoz
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HX575 epoetin alfa (Sandoz) in people with Chronic Kidney Disease, run by Sandoz at 50 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Russia, Ukraine, Poland, Romania, Germany and 2 more countries. 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 19 Jun 2017). 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?
Anti-Erythropoietin (EPO) Antibodies (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2017.