A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

Hoffmann-La Roche140 enrolled

Overview

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic renal anemia; * Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month; * Hb concentration between 10 and 12 g/dL; * Adequate iron status. Exclusion Criteria: * Transfusion of red blood cells during previous 2 months; * Significant acute or chronic bleeding, such as overt gastrointestinal bleeding; * Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months; * Active malignant disease.

Locations (34)

Unnamed facility

Barletta, Apulia, Italy

Unnamed facility

Molfetta (Ba), Apulia, Italy

Unnamed facility

Putignano, Apulia, Italy

Unnamed facility

Caserta, Campania, Italy

Unnamed facility

Eboli, Campania, Italy

Unnamed facility

Napoli, Campania, Italy

Unnamed facility

Nola, Campania, Italy

Unnamed facility

Solofra, Campania, Italy

Unnamed facility

Tivoli, Campania, Italy

Unnamed facility

Bologna, Emilia-Romagna, Italy

...and 24 more locations

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)

The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).

Time frame: EEP: Weeks 17 to 28

Secondary Outcomes

Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)

Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.

Time frame: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28

Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP

Time frame: EEP: Weeks 17 to 28

Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP

Time frame: EEP: Weeks 17 to 28

Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP

The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was \>1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

Time frame: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28

Percentage of Participants Who Required Red Blood Cell Transfusions

Time frame: Weeks 1 to 28