A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

Hoffmann-La Roche200 enrolled

Overview

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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

200

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: * adult patients, \>=18 years of age; * chronic renal anemia; * hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period; * continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months. Exclusion Criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * hemolysis; * folic acid and vitamin B12 deficiency.

Locations (18)

Unnamed facility

Kemerovo, Russia

Unnamed facility

Krasnodar, Russia

Unnamed facility

Moscow, Russia

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24

Time frame: EEP (Week 16 to Week 24)

Secondary Outcomes

Mean Change in Hb Concentration From Baseline to the EEP

A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24

Time frame: Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)

Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP

All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24

Time frame: EEP (Week 16 to Week 24)

Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP

The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24

Data from ClinicalTrials.gov

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