AnemiaPhase 3SWEEPNCT00869856
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
A Phase 3 study testing HX575 solution for s.c. administration in people with Anemia and Chronic Renal Insufficiency, run by Sandoz at 19 sites in 5 countries.
Trial summary
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c. Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chronic Renal Insufficiency
- What is being tested?
- HX575 solution for s.c. administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male and female CKD subjects with or without dialysis treatment
- Age > 18 years
- Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
- Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
- Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
- Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4
Who cannot join
- Systemic cyclosporine
- History of PRCA or aplastic anemia
- History of anti-EPO antibodies
- Uncontrolled hypertension
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Germany6 sites
KfH Nierenzentrum
Bad König, 64732
KfH Nierenzentrum
Berlin, 12045
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
Essen, 23538
Universitätsklinikum Schleswig-Holstein
Lübeck, 68309
Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis
Slzrx, 55232
Nierenzentrum Weinheim Kreiskrankenhaus Weinheim
Weinheim, 69469
Romania5 sites
Spitalul Clinic de Nefrologie Dr. Carol Davila
Bucharest, 010731
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Spitalul Judetean de Urgenta Deva
Deva, 330084
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
Oradea, 410169
Spitalul Clinic Judetean Timisoara
Timișoara, 300736
Bulgaria4 sites
MHAT "Dr. Tota Venkova"
Gabrovo, 5300
MHAT Pazardzhik
Pazardzhik, 4400
MHAT"Sveti Ivan Rilski"
Sofia, 1431
MHAT "Sveta Anna"
Varna, 9000
France2 sites
Polyclinique de Bordeaux-Nord
Bordeaux, 33077
Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren
Limoges, 87042
Spain2 sites
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
Hospital de Navarra
Pamplona, 31008
About this study
Official title: An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.
Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.
- Conditions
- Anemia, Chronic Renal Insufficiency
- Being tested
- HX575 solution for s.c. administration
- Keywords
- Treatment associated with CRI
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX575 solution for s.c. administrationDrug
Containing different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HX575, EPO Hexal Receives: Drug: HX575 solution for s.c. administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level
Measured: 36 weeks
Secondary outcomes (1)
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: investigation of adverse events in a related clinical study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karsten Roth, Study chair, Hexal AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869856
- Sponsor's protocol ID
- HX575-304
- Acronym
- SWEEP
- Status last verified
- Jun 2015
- First submitted
- 25 Mar 2009
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects
- ClinicalTrials.gov ID
- NCT00869856
- Acronym / sponsor ID
- SWEEP / HX575-304
- Conditions
- Anemia, Chronic Renal Insufficiency
- Keywords
- Treatment associated with CRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigation of adverse events in a related clinical study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.
Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HX575 solution for s.c. administrationHX575, EPO Hexal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female CKD subjects with or without dialysis treatment
- Age > 18 years
- Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
- Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
- Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
Key exclusion criteria (4 listed)
- Systemic cyclosporine
- History of PRCA or aplastic anemia
- History of anti-EPO antibodies
- Uncontrolled hypertension
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 solution for s.c. administrationContaining different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh | Drug | 1 |
Primary outcome
Change in hemoglobin level
Time frame: 36 weeks
1 secondary outcome
To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.
Time frame: 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
Karsten Roth study chair
Hexal AG
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HX575 solution for s.c. administration in people with Anemia and Chronic Renal Insufficiency, run by Sandoz at 19 sites in 5 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Romania, Bulgaria, France, Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 level (time frame: 36 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 2 Jun 2015.