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

Hoffmann-La Roche191 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

191

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (10)

Inje University Busan Paik Hospital; Nephrology

Busan, South Korea

Kyungpook National Uni Hospital; Internal Medicine

Daegu, South Korea

Chungnam National Uni Hospital; Nephrology

Daejeon, South Korea

Outcomes

Primary Outcomes

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.

Time frame: EEP (Weeks 17 to 24)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 1 to 24

Average Dose of Mircera Per Month

Data from ClinicalTrials.gov

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