AzTrials
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AnemiaPhase 3ORIONNCT00773968

A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

A Phase 3 study testing Methoxy Polyethylene Glycol-Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 34 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Methoxy Polyethylene Glycol-Epoetin Beta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
34 sitesItaly
Study dates
Sep 2008to Mar 2010
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

  • Chronic renal anemia;
  • Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
  • Hb concentration between 10 and 12 g/dL;
  • Adequate iron status.

Who cannot join

  • Transfusion of red blood cells during previous 2 months;
  • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
  • Active malignant disease.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Italy34 sites

  • Study site

    Albano Laziale, Lazio, 00041

  • Study site

    Alessandria, Piedmont, 15100

  • Study site

    Ancona, The Marches, 60131

  • Study site

    Barletta, Apulia, 70051

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Campobasso, Molise, 86100

  • Study site

    Caserta, Campania, 81100

  • Study site

    Catania, Sicily, 95124

  • Study site

    Chivasso, Piedmont, 10034

  • Study site

    Cinisello Balsamo, Lombardy, 20092

  • Study site

    Civita Castellana, Lazio, 01033

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Eboli, Campania, 84025

  • Study site

    Erice, Sicily, 91016

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Mantua, Lombardy, 46100

  • Study site

    Messina, Sicily, 98122

  • Study site

    Molfetta (Ba), Apulia, 70056

  • Study site

    Monza, Lombardy, 20052

  • Study site

    Naples, Campania, 80131

  • Study site

    Nola, Campania, 80035

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pesaro, The Marches, 61100

  • Study site

    Pistoia, Tuscany, 51100

  • Study site

    Pordenone, Friuli Venezia Giulia, 33170

  • Study site

    Putignano, Apulia, 70017

  • Study site

    S Fermo Della Battaglia, Lombardy, 22020

  • Study site

    Savona, Liguria, 17100

  • Study site

    Siena, Tuscany, 53100

  • Study site

    Solofra, Campania, 83029

  • Study site

    Tivoli, Campania, 00019

  • Study site

    Varese, Lombardy, 21100

  • Study site

    Viterbo, Lazio, 01100

Other trials in Italy

About this study

Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-Dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Conditions
Anemia
Being tested
Methoxy Polyethylene Glycol-Epoetin Beta
Medical subject headings
Anemia

What participants receive

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

  • Methoxy Polyethylene Glycol-Epoetin BetaDrug

    Also called CERA

    120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.

Study groups in NCT00773968
Study groupRoleWhat they receive
Methoxy Polyethylene Glycol-Epoetin BetaExperimentalParticipants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

What is being measured

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

  1. Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)

    The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).

    Measured: EEP: Weeks 17 to 28

Secondary outcomes (5)

  1. Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)

    Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.

    Measured: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28

  2. Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP

    Measured: EEP: Weeks 17 to 28

  3. Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP

    Measured: EEP: Weeks 17 to 28

  4. Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP

    The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

    Measured: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28

  5. Percentage of Participants Who Required Red Blood Cell Transfusions

    Measured: Weeks 1 to 28

Timeline

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

  1. First posted16 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00773968
Sponsor's protocol ID
ML21439
Other IDs
2008-003173-40, 2008
Acronym
ORION
Status last verified
Mar 2016
First submitted
15 Oct 2008
Last updated
4 Apr 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methoxy Polyethylene Glycol-Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 34 sites in Italy.

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 4 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: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Italy. 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 4 Apr 2016). 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?

Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) (time frame: EEP: Weeks 17 to 28). 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 NCT00773968.

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 4 Apr 2016.

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