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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 633-165
    • Inje University Busan Paik Hospital; Nephrology
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National Uni Hospital; Internal Medicine
  • Daejeon, Korea, Republic of, 301-721
    • Chungnam National Uni Hospital; Nephrology
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Kyonggi-do, Korea, Republic of, 411-719
    • NHIC Ilsan Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National Uni Hospital; Internal Medicine
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital; Division of Nephrology
  • Seoul, Korea, Republic of, 134-837
    • East-West Neo Medical Center; Division Of Nephology
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Centre; Department of Hematology & Oncology

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:

• 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 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: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
Average Dose of Mircera Per Month		Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2009
• Primary Completion (Actual): November 30, 2010
• Study Completion (Actual): November 30, 2010

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML22285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No