Study to Determine Optimum Intravenous Starting Dose of M... | NCT00717366

NCT00717366

ID	Type	Description	Link
2007-007758-70	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MIRCERA Group 1: Intermediate-Conversion-Factor Group	Experimental	Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.	Drug: Methoxy Polyethylene Glycol-Epoetin Beta
MIRCERA Group 2: High-Conversion-Factor Group	Experimental	Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.	Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methoxy Polyethylene Glycol-Epoetin Beta	Drug	Will be administered IV, every 4 weeks.	MIRCERA Group 1: Intermediate-Conversion-Factor Group MIRCERA Group 2: High-Conversion-Factor Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Average Hb Concentration Between Baseline and Evaluation Period	A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.	Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb	Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Royal Children'S Hospital; Department of Nephrology		Parkville	Victoria	3052	Australia
Hôpital Enfants Reine Fabiola

References Module

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IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received methoxy polyethylene glycol-epoetin beta (MIRCERA) intravenous (IV) injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-Stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

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No data is available for this block.

Intervention Browse Module

Masking Info

FG00016 subjects
FG00148 subjects

Intention-to-treat (ITT) population included all enrolled participants.

Arm/Group Information

ID	Title	Description
BG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
BG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (n=16,48)

Title	Measurements
	OG00011.26± 0.496 OG00111.08± 0.493

Change at Evaluation Period (n=12,36)

Title	Measurements
	OG000

Secondary

Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb

Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).

ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.

Posted

Number

participants

Evaluation Period (Week 17 to Week 21)

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL

The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).

Posted

Number

participants

Evaluation Period (Week 17 to Week 21)

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Number of Participants With Blood Transfusions

ITT population.

Posted

Number

participants

Baseline to Week 20

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Change in Average Reticulocyte Count Between the Baseline and Evaluation Period

A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.

ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.

Posted

Mean

Standard Deviation

10^3 cells/microliter

Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Maximum Observed Serum Concentration (Cmax) of MIRCERA

Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.

Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points.

Posted

Geometric Mean

Geometric Coefficient of Variation

picograms per milliliter (pg/mL)

Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group

Secondary

Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA

Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).

PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.

Posted

Geometric Mean

Geometric Coefficient of Variation

picograms*hour/milliliter (pg*h/mL)

Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Time to Reach Cmax (Tmax) of MIRCERA

Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.

PK evaluable population.

Posted

Median

Full Range

hours

Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Secondary

Apparent Terminal Phase Half-Life (t1/2) of MIRCERA

t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.

PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13

ID	Title	Description
OG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
OG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MIRCERA Group 1: Intermediate-Conversion-Factor Group	Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.			4	16	11	16
EG001	MIRCERA Group 2: High-Conversion-Factor Group	Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.			17	48	28	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Device related infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Orchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Staphylococcal scalded skin syndrome	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0012 affected48 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0012 affected48 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Thrombosis in device	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Device dislocation	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
Pericarditis	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Intracranial haematoma	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected48 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG00114 affected48 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0013 affected48 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0012 affected48 at risk
Viral infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0012 affected48 at risk
Catheter site infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
H1N1 influenza	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected48 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Oral herpes	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG00113 affected48 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected16 at risk EG0015 affected48 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0013 affected48 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0019 affected48 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0013 affected48 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0014 affected48 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0012 affected48 at risk
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0013 affected48 at risk
Malaise	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0014 affected48 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected16 at risk EG0013 affected48 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected48 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk
Haemoglobin decreased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected48 at risk

ID	Term
C508420	continuous erythropoietin receptor activator

Units	Counts
Participants	OG00016 OG00148

Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.