A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

Hoffmann-La Roche65 enrolled

Overview

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

Differing doses and frequencies of sc administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * not receiving renal replacement therapy. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Locations (15)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

Detroit, Michigan, United States

Outcomes

Primary Outcomes

The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes

The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.

Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Secondary Outcomes

Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen

Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.

Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen

Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.

Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Number of Participants With Any Serious Adverse Events and Any Adverse Events

Data from ClinicalTrials.gov

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An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.

Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time

Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10\^9 cells/L), platelets (100-550 10\^9 cells/L), alanine aminotransferase (ALT) \[0-110 units per litre (U/L)\], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin \>= 30 g/L, phosphate \[0.75 - 1.60 millimoles per liter (mmol/L)\], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10\^9 cells/L), eosinophils (0 - 0.45 10\^9 cells/L), monocytes (0 - 0.8 10\^9 cells/L), and neutrophils (1.80 - 7.70 10\^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only.

Time frame: Up to Week 125