A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

Phase 3TerminatedNCT00462384

Hoffmann-La Roche39 enrolled

Overview

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). 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

Conditions

Anemia

Interventions

Methoxy Polyethylene Glycol-epoetin BetaDRUG

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic kidney disease, stage 3 or 4; * anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]). Exclusion Criteria: * previous therapy with ESA within 12 weeks prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * red blood cell transfusions within 8 weeks before screening; * active malignant disease (except non-melanoma skin cancer).

Locations (22)

Unnamed facility

Tallinn, Estonia

Unnamed facility

Tallinn, Estonia

Unnamed facility

Tartu, Estonia

Outcomes

Primary Outcomes

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)

The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.

Time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)

Secondary Outcomes

Time to Achievement of Response

Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.

Time frame: Baseline to Week 40

Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.

Time frame: EEP (Weeks 29 to 36)

Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.

Time frame: EEP (Weeks 29 to 36)

Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP

EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.

Time frame: EEP (Weeks 29 to 36)

Data from ClinicalTrials.gov

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