An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02263833
• Collaborator: (none)
• Enrollment: 748
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 21.4

Study Details

Study Description

Brief Summary

This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.

Condition or Disease	Intervention/Treatment	Phase
Kidney Disease, Chronic	Drug: Mircera

Study Design

• Study Type: Observational
• Actual Enrollment: 748 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance of Mircera®
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Overall Participants Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera	Drug: Mircera; Participants received Mircera according to individualized physician-prescribed regimen.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event [At physician's discretion, up to 4 years]

   An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.

2. Percentage of Participants With an Adverse Drug Reaction (ADR) [At physician's discretion, up to 4 years]

   ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.

Other Outcome Measures

1. Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion [Up to 4 years]

2. Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL [Up to 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult, aged >18 years

• Participants with stage 3-5 chronic kidney disease and hemodialyzed participants

• Signed informed consent

Exclusion Criteria:

• Current participation in a clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02263833
• Other Study ID Numbers: ML22560
• First Posted: Oct 13, 2014
• Last Update Posted: Sep 7, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

Participant Flow

Pre-assignment Detail	In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.

Arm/Group Title	Overall Participants
Arm/Group Description	Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Period Title: Overall Study
STARTED	742
COMPLETED	742
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Overall Participants	742
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.7 (14.2)
Sex: Female, Male (Count of Participants)
Female	376 50.7%
Male	366 49.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
Description	An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame	At physician's discretion, up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.

Arm/Group Title	Overall Participants
Arm/Group Description	Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Measure Participants	742
Adverse event	3 0.4%
Serious adverse event	0.40 0.1%

2. Primary Outcome

Title	Percentage of Participants With an Adverse Drug Reaction (ADR)
Description	ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Time Frame	At physician's discretion, up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.

Arm/Group Title	Overall Participants
Arm/Group Description	Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Measure Participants	742
Number [percentage of participants]	2.0 0.3%

3. Other Pre-specified Outcome

Title	Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Up to 4 years
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Arm/Group Title	Overall Participants
Arm/Group Description	Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
All Cause Mortality
	Overall Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	3/742 (0.4%)
Cardiac disorders
Atrioventricular block	1/742 (0.1%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	1/742 (0.1%)
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema	1/742 (0.1%)
Other (Not Including Serious) Adverse Events
	Overall Participants
	Affected / at Risk (%)	# Events
Total	0/742 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.