An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01677767

First received: August 30, 2012

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2012

Last Updated Date

May 7, 2013

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical/demographic patient characteristics at initiation of treatment with Mircera [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Mean time to achieve target Hb range (Hb 10-12 g/dL) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Maintenance of Hb levels (patients on ESA with HB 10-12 g/dL): Percentage of patients maintaining Hb level within 1 g/dL of baseline during study period (24 weeks) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01677767 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of patients achieving Hb target range (Hb 10-12 g/dL) at least once during study treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Maintenance: Mean time spent on Hb level 10-12 g/dL [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Dosage/administration route [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

Official Title ^ICMJE

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

Brief Summary

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

Condition ^ICMJE

Anemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

103

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, 18 to 65 years of age, inclusive
Patients with chronic kidney disease on dialysis
ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate irons status as judged by the treating physician

Exclusion Criteria:

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months
Pregnant women
Contraindications for Mircera according to local prescribing information or as judged by the investigator

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01677767

Other Study ID Numbers ^ICMJE

ML25475

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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