A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

Hoffmann-La Roche208 enrolled

Overview

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Chronic Renal Anemia

Interventions

Methoxy polyethylene glycol-epoetin betaDRUG

Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults greater than or equal to (≥) 18 years of age * Chronic renal anemia * Stable epoetin alfa or darbepoetin alfa therapy for past 2 months * Hemodialysis therapy for ≥3 months Exclusion Criteria: * Transfusion of red blood cells during previous 2 months * Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months * Acute or chronic bleeding

Locations (24)

Unnamed facility

Aigáleo, Greece

Unnamed facility

Athens, Greece

Unnamed facility

Athens, Greece

Outcomes

Primary Outcomes

Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.

Time frame: Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Secondary Outcomes

Mean Change in Time-Adjusted Hb From Baseline to EEP

Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.

Time frame: At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP

During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.

Time frame: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24

Data from ClinicalTrials.gov

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