ORION Study: A Study of Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia

Anemia Clinical Trial

Official title:

"A Single Arm, Open Label Study Evaluating Once-monthly Subcutaneous Mircera for the Maintenance of Hemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anemia"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773968
• Other study ID #: ML21439
• Secondary ID: 2008-003173-40
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2008
• Last updated: December 1, 2015
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the long term maintenance of hemoglobin levels, safety and tolerability of once monthly subcutaneous Mircera in predialysis patients with chronic renal anemia. Patients currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous Mircera 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 g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size if 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >= 18 years of age;

• 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP)		Weeks 17-28	No
Secondary	Change in Hb concentration between reference (SVP) and the EEP; Proportion of patients maintaining Hb levels within the range 10-12 g/dL throughout the EEP; Median time spent in Hb concentration range 10-12 g/dL		Weeks 17-28	No
Secondary	Proportion of patients requiring any dose adjustment; incidence of red blood cell transfusions; adverse events, vital signs, ECG; laboratory safety paramenters.		Throughout study	No