A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

Anemia Clinical Trial

Official title:

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922116
• Other study ID #: ML22285
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2009
• Last updated: November 4, 2015
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea:FDA
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: November 2010
• Est. primary completion date: November 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 maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• active malignant disease (except non-melanoma skin cancer).

Study Design

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]
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)	The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.	EEP (Weeks 17 to 24)	No
Secondary	Change in Hemoglobin Concentration Between SVP and the EEP	Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.	SVP (Baseline), and EEP (Weeks 17 to 24)	No
Secondary	Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP	EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.	EEP (Weeks 17 to 24)	No
Secondary	Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP	DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.	Weeks 1 to 24	No
Secondary	Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP	DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.	Weeks 1 to 24	No
Secondary	Average Dose of Mircera Per Month		Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24	No