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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Methoxy Polyethylene Glycol-Epoetin Beta
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methoxy Polyethylene Glycol-Epoetin Beta

Arm Description

Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.

Outcomes

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)
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)
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
Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP
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.
Percentage of Participants Who Required Red Blood Cell Transfusions

Full Information

First Posted
October 15, 2008
Last Updated
March 4, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00773968
Brief Title
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
Acronym
ORION
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxy Polyethylene Glycol-Epoetin Beta
Arm Type
Experimental
Arm Description
Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
Intervention Type
Drug
Intervention Name(s)
Methoxy Polyethylene Glycol-Epoetin Beta
Other Intervention Name(s)
CERA
Intervention Description
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
EEP: Weeks 17 to 28
Secondary Outcome Measure Information:
Title
Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)
Description
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.
Time Frame
SVP: Week -4 to Week 0; EEP: Weeks 17 to 28
Title
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
Title
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
Title
Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
Description
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.
Time Frame
DTP: Weeks 1 to 16; EEP: Weeks 17 to 28
Title
Percentage of Participants Who Required Red Blood Cell Transfusions
Time Frame
Weeks 1 to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Caserta
State/Province
Campania
ZIP/Postal Code
81100
Country
Italy
City
Eboli
State/Province
Campania
ZIP/Postal Code
84025
Country
Italy
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Nola
State/Province
Campania
ZIP/Postal Code
80035
Country
Italy
City
Solofra
State/Province
Campania
ZIP/Postal Code
83029
Country
Italy
City
Tivoli
State/Province
Campania
ZIP/Postal Code
00019
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Pordenone
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
City
Albano Laziale
State/Province
Lazio
ZIP/Postal Code
00041
Country
Italy
City
Civita Castellana
State/Province
Lazio
ZIP/Postal Code
01033
Country
Italy
City
Viterbo
State/Province
Lazio
ZIP/Postal Code
01100
Country
Italy
City
Savona
State/Province
Liguria
ZIP/Postal Code
17100
Country
Italy
City
Cinisello Balsamo
State/Province
Lombardia
ZIP/Postal Code
20092
Country
Italy
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
City
Mantova
State/Province
Lombardia
ZIP/Postal Code
46100
Country
Italy
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
S Fermo Della Battaglia
State/Province
Lombardia
ZIP/Postal Code
22020
Country
Italy
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21100
Country
Italy
City
Ancona
State/Province
Marche
ZIP/Postal Code
60131
Country
Italy
City
Pesaro
State/Province
Marche
ZIP/Postal Code
61100
Country
Italy
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86100
Country
Italy
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15100
Country
Italy
City
Chivasso
State/Province
Piemonte
ZIP/Postal Code
10034
Country
Italy
City
Barletta
State/Province
Puglia
ZIP/Postal Code
70051
Country
Italy
City
Molfetta (Ba)
State/Province
Puglia
ZIP/Postal Code
70056
Country
Italy
City
Putignano
State/Province
Puglia
ZIP/Postal Code
70017
Country
Italy
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95124
Country
Italy
City
Erice
State/Province
Sicilia
ZIP/Postal Code
91016
Country
Italy
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98122
Country
Italy
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
City
Lido Di Camaiore
State/Province
Toscana
ZIP/Postal Code
55043
Country
Italy
City
Pistoia
State/Province
Toscana
ZIP/Postal Code
51100
Country
Italy
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

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

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