STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

Hoffmann-La Roche188 enrolled

Overview

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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

188

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

120, 200 or 360 micrograms iv monthly (starting dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic renal anemia; * Continuous stable intravenous maintenance epoetin therapy during previous month; * Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months. Exclusion Criteria: * Transfusion of red blood cells during previous 2 months; * Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication; * Significant acute or chronic bleeding.

Locations (24)

Unnamed facility

Brno, Czechia

Unnamed facility

Český Krumlov, Czechia

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.

Time frame: Week 17 up to Week 24

Secondary Outcomes

Change in Hemoglobin Concentration Between Reference (SVP) and EEP

The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.

Time frame: Week -4 up to Week -1 and Week 17 up to Week 24

Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

Time frame: Week 17 up to Week 24

Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

Time frame: Week 17 up to Week 24

Percentage of Participants Requiring Any Dose Adjustment

Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.

Data from ClinicalTrials.gov

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