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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773968
First received: October 15, 2008
Last updated: March 4, 2016
Last verified: March 2016
  Purpose
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).

Condition Intervention Phase
Anemia
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change in Hb Concentrations Between EEP and Stability Verification Period (SVP) [ Time Frame: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP [ Time Frame: EEP: Weeks 17 to 28 ] [ Designated as safety issue: No ]
  • Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP [ Time Frame: EEP: Weeks 17 to 28 ] [ Designated as safety issue: No ]
  • Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP [ Time Frame: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Required Red Blood Cell Transfusions [ Time Frame: Weeks 1 to 28 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
Other Name: CERA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773968

Locations
Italy
Caserta, Campania, Italy, 81100
Eboli, Campania, Italy, 84025
Napoli, Campania, Italy, 80131
Nola, Campania, Italy, 80035
Solofra, Campania, Italy, 83029
Tivoli, Campania, Italy, 00019
Bologna, Emilia-Romagna, Italy, 40138
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Albano Laziale, Lazio, Italy, 00041
Civita Castellana, Lazio, Italy, 01033
Viterbo, Lazio, Italy, 01100
Savona, Liguria, Italy, 17100
Cinisello Balsamo, Lombardia, Italy, 20092
Cremona, Lombardia, Italy, 26100
Mantova, Lombardia, Italy, 46100
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
S Fermo Della Battaglia, Lombardia, Italy, 22020
Varese, Lombardia, Italy, 21100
Ancona, Marche, Italy, 60131
Pesaro, Marche, Italy, 61100
Campobasso, Molise, Italy, 86100
Alessandria, Piemonte, Italy, 15100
Chivasso, Piemonte, Italy, 10034
Barletta, Puglia, Italy, 70051
Molfetta (Ba), Puglia, Italy, 70056
Putignano, Puglia, Italy, 70017
Catania, Sicilia, Italy, 95124
Erice, Sicilia, Italy, 91016
Messina, Sicilia, Italy, 98122
Palermo, Sicilia, Italy, 90127
Lido Di Camaiore, Toscana, Italy, 55043
Pistoia, Toscana, Italy, 51100
Siena, Toscana, Italy, 53100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773968     History of Changes
Other Study ID Numbers: ML21439  2008-003173-40 
Study First Received: October 15, 2008
Results First Received: March 4, 2016
Last Updated: March 4, 2016
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on September 27, 2016