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

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).

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Campania
    • Caserta, Campania, Italy, 81100
    • Eboli, Campania, Italy, 84025
    • Napoli, Campania, Italy, 80131
    • Nola, Campania, Italy, 80035
    • Solofra, Campania, Italy, 83029
    • Tivoli, Campania, Italy, 00019
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
  • Friuli-Venezia Giulia
    • Pordenone, Friuli-Venezia Giulia, Italy, 33170
  • Lazio
    • Albano Laziale, Lazio, Italy, 00041
    • Civita Castellana, Lazio, Italy, 01033
    • Viterbo, Lazio, Italy, 01100
  • Liguria
    • Savona, Liguria, Italy, 17100
  • Lombardia
    • 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
  • Marche
    • Ancona, Marche, Italy, 60131
    • Pesaro, Marche, Italy, 61100
  • Molise
    • Campobasso, Molise, Italy, 86100
  • Piemonte
    • Alessandria, Piemonte, Italy, 15100
    • Chivasso, Piemonte, Italy, 10034
  • Puglia
    • Barletta, Puglia, Italy, 70051
    • Molfetta (Ba), Puglia, Italy, 70056
    • Putignano, Puglia, Italy, 70017
  • Sicilia
    • Catania, Sicilia, Italy, 95124
    • Erice, Sicilia, Italy, 91016
    • Messina, Sicilia, Italy, 98122
    • Palermo, Sicilia, Italy, 90127
  • Toscana
    • Lido Di Camaiore, Toscana, Italy, 55043
    • Pistoia, Toscana, Italy, 51100
    • Siena, Toscana, Italy, 53100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CERA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	EEP: Weeks 17 to 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	SVP: Week -4 to Week 0; EEP: Weeks 17 to 28
Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP		EEP: Weeks 17 to 28
Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP		EEP: Weeks 17 to 28
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.	DTP: Weeks 1 to 16; EEP: Weeks 17 to 28
Percentage of Participants Who Required Red Blood Cell Transfusions		Weeks 1 to 28

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 15, 2008
• First Posted (Estimate): October 16, 2008

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21439; 2008-003173-40 (EudraCT Number)