AnemiaPhase 3NCT00666835
Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
A Phase 3 study testing HX575 epoetin alfa Hexal AG and ERYPO®, Janssen-Cilag in people with Anemia, run by Sandoz at 54 sites in 2 countries.
Trial summary
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- HX575 epoetin alfa Hexal AG and ERYPO®, Janssen-Cilag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Apr 2004to Jan 2006
- 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
Who may be able to join
- Receiving dialysis for at least 6 months (3 times weekly) before screening
- Age: >=18
- Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening
- Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before screening and during screening with a maximal weekly dosage of 300 IU/kg body weight (stable is defined as <25% change (up or down) in weekly dose and no change in frequency over 8 weeks prior screening and 10 weeks prior randomisation)
- Baseline hemoglobin concentration of 10.0 to 13.0 g/dl (mean of two pre-randomization pre-dialysis samples of Hb at visit -2 and visit 1)
- Serum ferritin >=100 µg/l and/or saturated transferrin levels >=20%
Show all 9Show fewer
- C-reactive protein <15 mg/l (< 5 mg/l: normal; >= 5 mg/l < 10 mg/l: +; >=10mg/l < 100 mg/l: ++; >=100 mg/l: +++)
- Ability to follow study instructions and likely to complete all required visits
- Written informed consent of the patient
Who cannot join
- Anemia of non-renal causes
- Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
- Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range)
- Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone >1500 pg/mL).
- Known history of bone marrow disease
- Any red blood cell transfusion(s) during the last 12 weeks before screening or during the screening/baseline period
Show all 28Show fewer
- Insufficient concomitant iron treatment during the last 2 months before Visit -2
- Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement >=110 mmHg during the screening period
- Congestive heart failure [New York Heart Association (NYHA) class III and IV]
- Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
- History of blood coagulation disease
- Thrombocytopenia (platelet count <100.000/µl)
- Leukopenia (white blood cell count < 2.000/µl)
- Overt bleeding (acute or chronic bleeding within 2 months of inclusion) or hemolysis
- Evidence of acute infectious disease or serious active inflammatory states within one months before screening (Visit -2) or during the screening/baseline period
- Suspicion or known PRCA (pure red cell aplasia)
- Previously diagnosed HIV or acute hepatitis infection
- Treatment for epilepsy within the past 6 months
- Planned surgery during the next 7 months (except vascular access surgery)
- Any androgen therapy within 2 months before visit -2 and during the study
- Therapy with immunosuppressants or any drug known to affect the hematocrit within 1 month before Visit -2 and during the study
- Clinical evidence of malignant diseases
- Pregnancy, breastfeeding women or women not using adequate birth control measures
- Known history of severe drug related allergies
- Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
- Simultaneous participation in another clinical study or participation in a study in the month preceding the start of this study or previously randomized in this study
- Participation in an erythropoietin study in the 3 months preceding screening (visit -2)
- Any other condition which at the investigator´s discretion may put the patient at risk or which may confound the study results
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
Germany45 sites
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Aschaffenburg
Dialysepraxis Bad Münder
Bad Münder am Deister
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Bad Nauheim
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Bamberg
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Bayreuth
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Bergisch Gladbach
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Berlin
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Bischofswerda
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Bremerhaven
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Coburg
Dialysepraxis Drs. Riedasch/Schreiber
Coesfeld
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Deggendorf
Dialysepraxis
Donaueschingen
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Eberswalde
Dialysepraxis Dr. med. Stefan Holzmann
Erkelenz
Dialysepraxis Dr. Möller, Dr. Knee
Essen
Dialysepraxis
Freiberg
Dialysezentrum
Freiburg im Breisgau
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Fürstenzell
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Greifswald
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Gummersbach
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Günzburg
Praxis Dres. Sohn und Schaumann
Hamelin
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Hanover
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Haßfurt
Dialysepraxis Dr. med. Stefan Holzmann
Heinsberg
Praxis Dr. Kienle
Homberg (Efze)
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Ingolstadt
KfH - Prof. Dr. med. Heide Sperschneider
Jena
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Kronach
Dialysepraxis Dr. med. Matthias Anders
Leipzig
Kfh Kuratorium für Dialyse & Nierentransplantation e.V., 2.Etage
Leipzig
KfH Kuratorium für Nierentranplantation und Dialyse e.V.
Lohr
Dialysepraxis Prof. Rob, Dr. Wilhelm u. Dr. Schümann
Lübeck
Dialysepraxis Dr.med. H.-D. Hoffmann
Menden
KfH Kuratorium für Dialyse und Nierentransplantation e.V
München
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Neuried
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Nördlingen
Gemeinschaftspraxis Dr.Steger, Dr.Böhmer, Dr.Kirpal
Nuremberg
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Oberschleißheim
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Plauen
Dialysezentrum
Potsdam
Praxis Dres.Hartmann, Schiele
Saarbrücken
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Straubing
KfH Kuratorium für Dialyse und Nierentransplantation e.V
Sulzbach-Rosenberg
Austria9 sites
Landeskrankenhaus Feldkirch
Feldkirch
Allgemeines Krankenhaus der Barmherzigen Brüder Graz
Graz
Dialyseinstitut Graz GmbH
Graz
Krankenhaus der Elisabethinen
Graz
Universitätsklinik Innsbruck, Klinische Abteilung für Nephrologie
Innsbruck
Allgemeines Öffentliches Krankenhaus St. Pölten, I. Med. Abteilung
Sankt Pölten
Allgemeines öffentliches Krankenhaus Wiener Neustadt , 2. Interne Abteilung
Vienna
Krankenanstalt Rudolfstiftung der Stadt Wien, 3. Med. Abteilung
Vienna
Wilhelminenspital der Stadt Wien, Abt. für Nephrologie und Dialyse
Vienna
About this study
Official title: Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.
Read the detailed description
The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.
- Conditions
- Anemia
- Being tested
- HX575 epoetin alfa Hexal AG, ERYPO®, Janssen-Cilag
- Keywords
- Treatment of anemia in hemodialysis patients
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX575 epoetin alfa Hexal AGDrug
Also called Binocrit, Abseamed
HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
ERYPO®, Janssen-CilagDrug
Also called EPREX®, Solution for i.v. injection
Solution for i.v. injection
| Study group | Role | What they receive |
|---|---|---|
| HX575 epoetin alfa Hexal AG | Experimental | Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Receives: Drug: HX575 epoetin alfa Hexal AG |
| ERYPO®, Janssen-Cilag | Active comparator | Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Receives: Drug: ERYPO®, Janssen-Cilag |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.
Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.
Measured: 28 weeks
Secondary outcomes (1)
Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population
The mean absolute change in Hb levels between the screening/baseline period and the evaluation period was analyzed for the intent-to-treat (ITT) population in the same way as the primary efficacy endpoint. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between HX575 epoetin alfa Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL].
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2004
- Primary completionJan 2006
- Study completionJan 2006
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 AnemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Responsible party
- Sponsor
- Investigators
- Marianne Haag-Weber, Prof., Principal investigator, Dialysezentrum Straubing, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666835
- Sponsor's protocol ID
- 2003-29-INJ-9
- Status last verified
- Jun 2023
- First submitted
- 23 Apr 2008
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00666835
- Acronym / sponsor ID
- 2003-29-INJ-9
- Conditions
- Anemia
- Keywords
- Treatment of anemia in hemodialysis patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Study start
- Apr 2004 (actual)
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.
Detailed description
The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HX575 epoetin alfa Hexal AG | Experimental | Drug: HX575 epoetin alfa Hexal AGEligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. |
| ERYPO®, Janssen-Cilag | Active comparator | Drug: ERYPO®, Janssen-CilagEligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Receiving dialysis for at least 6 months (3 times weekly) before screening
- Age: >=18
- Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening
- Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before screening and during screening with a maximal weekly dosage of 300 IU/kg body weight (stable is defined as <25% change (up or down) in weekly dose and no change in frequency over 8 weeks prior screening and 10 weeks prior randomisation)
- Baseline hemoglobin concentration of 10.0 to 13.0 g/dl (mean of two pre-randomization pre-dialysis samples of Hb at visit -2 and visit 1)
Key exclusion criteria (28 listed)
- Anemia of non-renal causes
- Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
- Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range)
- Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone >1500 pg/mL).
- Known history of bone marrow disease
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 Hexal AGAlso: Binocrit, AbseamedHX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin | Drug | HX575 epoetin alfa Hexal AG |
| ERYPO®, Janssen-CilagAlso: EPREX®, Solution for i.v. injectionSolution for i.v. injection | Drug | ERYPO®, Janssen-Cilag |
Primary outcome
To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.
Time frame: 28 weeks
Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.
1 secondary outcome
Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population
Time frame: 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- 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.
Marianne Haag-Weber, Prof. principal investigator
Dialysezentrum Straubing, Germany
54 sites in 2 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 Hexal AG and ERYPO®, Janssen-Cilag in people with Anemia, run by Sandoz at 54 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 9 inclusion and 28 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, Austria. 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 2 Aug 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?
To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag. (time frame: 28 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 3 Jul 2023.