AnemiaPhase 3NCT00450333
Dynepo Infrequent Dosing Study
A Phase 3 study testing Dynepo (Epoetin delta) and Dynepo in people with Anemia and Kidney Failure, run by Shire at 53 sites in 7 countries.
Trial summary
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Kidney Failure
- What is being tested?
- Dynepo (Epoetin delta) and Dynepo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 53 sitesin 7 countries
- Study dates
- 30 Oct 2006to 31 Jul 2008
- 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
- Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
- Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
- Transferrin saturation >= 20% and ferritin >= 100 ng/mL.
Who cannot join
- Uncontrolled hypertension.
- Requiring doses of EPO > 10,000 IU/week.
- Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
- Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
- Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
- Androgen therapy in the 30 days immediately prior to randomisation in the study.
- Known Human Immunodeficiency Virus(HIV)infection.
- History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
France10 sites
CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
Bordeaux, 33076
CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
Boulogne-sur-Mer, 62321
Hopital Clemenceau, Nephrologie-Hemodialyse
Caen, 14033
CHU (Centre Hospitalier Universitaire)
Grenoble, 38043
CHU Hotel Dieu, Service du Pr Soulillou
Nantes, 44093
Clinique de Landy, Service de Nephrologie - Hemodialyse
Saint-Ouen, 93400
Hopital Sud, Service du Pr Fournier
Salouël, 80480
CHU Hopital Civil, Nephrologie-Hemodialyse
Strasbourg, 67091
Hopital Rangueil, Service du Pr Durand
Toulouse, 31403
Hopital Brabois Adultes, Nephrologie
Vandœuvre-lès-Nancy, 54511
Germany10 sites
Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
Aachen, North Rhine-Westphalia, 52074
KfH Nierenzentrum Bamberg
Bamberg, Bavaria, 96050
Praxis Dr. Vosskuhler
Bottrop, North Rhine-Westphalia, 46242
Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
Düsseldorf, North Rhine-Westphalia, 40210
KfH Nierenzentrum Fulda
Fulda, Hesse, 36043
KfK Nierenzentrum Nurnberg
Nuremberg, 90471
Dialyse-und Apheresezentrum Potsdam-Bebelsberg
Potsdam, Brandenburg, 14482
KfH Nierenzebtrum im Linikum Rosenheim
Rosenheim, Bavern, 83022
KfH Nierenzentrum am Handr-Klinikum Stralsund
Stralsund, Mecklenburg-Vorpommern, 18435
Nephrologische Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, 78054
Italy10 sites
Policlinico S. Orsola Malpighi
Bologna, Emilia-Romagna, 40138
Spedali Civil Brescia
Brescia, Lombardy, 25123
Ospedali Riuniti
Foggia, Apulia, 71100
Ospedale Nuovo Alessandro Manzoni
Lecco, Lombardy, 23900
Azienda Ospedaliera Universitaria Policlinico di Modena
Modena, Emillia Romagna, 41100
Universita' degli Studi di Napoli Federico II
Naples, Campania, 80131
A.R.N.A.S Civico Palermo
Palermo, Sicily, 90127
Azienda Sanitaria Locale 4 Area Pratese
Prato, Tuscany, 59100
Azienda Ospedaliera S.Giovanni-Addolorata
Rome, Lazio, 00184
Azienda Ospedaliera CTO/CRF/M.Adelaide
Turin, Piedmont, 10126
Spain10 sites
Head of Nephrology, Fundacion Puigvert
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hotel General Universitario
Castellon, Castellon, 120004
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Gregorio Maranon
Madrid, 28007
Hospital Central de Asturias
Oviedo, 33006
Hospital Puerto Real
Puerto Real, Cadiz, 11510
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Doctor Peset
Valencia, 46017
United Kingdom8 sites
Richard Bright Renal Unit Southmead Hospital
Bristol, BS10 5NB
Addenbrooke's Hospital
Cambridge, CB2 0QQ
University Hospital of Wales
Cardiff, CF14 4XW
Glasgow Western Infirmary
Glasgow, G11 6NT
Kings College Hospital Renal Unit
London, SE5 9RS
Hope Hospital
Salford, Manchester, M6 8HD
Morrison Hospital
Swansea, SA6 6NL
New Cross Hospital
Wolverhampton, WV10 0QP
Belgium3 sites
Hopital UCL, Service de Nephrologie
Brussels, B-1200
UZ Gasthuisberg, Leuve, Dept of Nephrology
Leuven, B-3000
Hellig Hart Ziekenhuis, Campus Wilgenstraat
Roeselare, B-8800
Austria2 sites
Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
Graz, Steiemark, A-8036
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
Innsbruck, A-6020
About this study
Official title: An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
- Conditions
- Anemia, Kidney Failure
- Being tested
- Dynepo (Epoetin delta), Dynepo
- Keywords
- Chronic
- Medical subject headings
- Anemia, Renal Insufficiency, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynepo (Epoetin delta)Drug
subcutaneous, BIW for 24 weeks
DynepoDrug
subcutaneous, QW for 24 weeks
DynepoDrug
subcutaneous, QW for 24 weeks
DynepoDrug
subcutaneous, Q2W for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Erythropoietin(EPO)-naive BIW Receives: Drug: Dynepo (Epoetin delta) |
| 2 | Active comparator | EPO-naive QW Receives: Drug: Dynepo |
| 3 | Active comparator | EPO QW Receives: Drug: Dynepo |
| 4 | Active comparator | EPO Q2W Receives: Drug: Dynepo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Measured: Baseline and 24 weeks
Secondary outcomes (2)
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Measured: week 16 and 24
Change From Baseline in Hematocrits at 16 and 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Measured: Baseline and Weeks 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study start30 Oct 2006
- Primary completion31 Jul 2008
- Study completion31 Jul 2008
Why it stopped: The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450333
- Sponsor's protocol ID
- SPD490-301
- Other IDs
- 2006-002052-15
- Status last verified
- Jun 2021
- First submitted
- 21 Mar 2007
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.
PubMed 17999759
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
- ClinicalTrials.gov ID
- NCT00450333
- Acronym / sponsor ID
- SPD490-301
- Conditions
- Anemia, Kidney Failure
- Keywords
- Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA
- Enrolment
- 407 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2006 (actual)
- Primary completion
- 31 Jul 2008 (actual)
- Study completion
- 31 Jul 2008 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 10 Nov 2009
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 this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Dynepo (Epoetin delta)Erythropoietin(EPO)-naive BIW |
| 2 | Active comparator | Drug: DynepoEPO-naive QW |
| 3 | Active comparator | Drug: DynepoEPO QW |
| 4 | Active comparator | Drug: DynepoEPO Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
- Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
- Transferrin saturation >= 20% and ferritin >= 100 ng/mL.
Key exclusion criteria (8 listed)
- Uncontrolled hypertension.
- Requiring doses of EPO > 10,000 IU/week.
- Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
- Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
- Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
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 |
|---|---|---|
| Dynepo (Epoetin delta)subcutaneous, BIW for 24 weeks | Drug | 1 |
| Dyneposubcutaneous, QW for 24 weeks | Drug | 2 |
| Dyneposubcutaneous, QW for 24 weeks | Drug | 3 |
| Dyneposubcutaneous, Q2W for 24 weeks | Drug | 4 |
Primary outcome
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
Time frame: Baseline and 24 weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
2 secondary outcomes
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
Time frame: week 16 and 24
Change From Baseline in Hematocrits at 16 and 24 Weeks
Time frame: Baseline and Weeks 16 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Derived from this study: PubMed 17999759Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.
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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.
Study Director study director
Takeda
53 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 Dynepo (Epoetin delta) and Dynepo in people with Anemia and Kidney Failure, run by Shire at 53 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?
The sponsor lists 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, Germany, Italy, Spain, United Kingdom 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 10 Nov 2009). 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 From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks (time frame: Baseline and 24 weeks). 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 NCT00450333, which also lists 2 linked publications.
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 14 Jun 2021.