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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT00576303
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Start: 2008-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2016-04
• Results First Submitted: 2016-04-20
• Results First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO0503821 (C.E.R.A.), 1x/4weeks	methoxy polyethylene glycol-epoetin beta [Mircera]	Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks

Primary Outcome Measures

Name	Time	Method
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	EEP (Week 16 to Week 24)	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

Secondary Outcome Measures

Name	Time	Method
Mean Change in Hb Concentration From Baseline to the EEP	Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)	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
Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP	EEP (Week 16 to Week 24)	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
Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP	EEP (Week 16 to Week 24)	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
Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP	DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)	The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44
Number of Participants With Red Blood Cell Transfusion	Up to 3 years	The number of participants who underwent red blood cell transfusion was reported