An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

June 13, 2017 updated by: Hoffmann-La Roche

The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Novy Jicin, Czechia, 741 11
        • Nemocnice Novy Jicin; Dialyzacni Stredisko

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic kidney disease receiving Mircera treatment

Description

Inclusion Criteria:

  • Adults patients, >/=18 years of age
  • Presence of chronic kidney disease (Stage 3-4)

Exclusion Criteria:

  • Participation in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Kidney Disease
Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Dose of MIRCERA at Entry Level
Time Frame: Baseline
The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Baseline
Average Dose of MIRCERA During Titration Period Month 1
Time Frame: Month 1
The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Month 1
Average Dose of MIRCERA During Titration Period Month 2
Time Frame: Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Month 2
Average Dose of MIRCERA During Titration Period Month 3
Time Frame: Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Month 3
Average Dose of MIRCERA During Titration Period Month 4
Time Frame: Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Month 4
Average Dose of MIRCERA During Maintenance Period Month 1
Time Frame: Month 5 (Maintenance Period Month 1)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 5 (Maintenance Period Month 1)
Average Dose of MIRCERA During Maintenance Period Month 2
Time Frame: Month 6 (Maintenance Period Month 2)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 6 (Maintenance Period Month 2)
Average Dose of MIRCERA During Maintenance Period Month 3
Time Frame: Month 7 (Maintenance Period Month 3)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 7 (Maintenance Period Month 3)
Average Dose of MIRCERA During Maintenance Period Month 4
Time Frame: Month 8 (Maintenance Period Month 4)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 8 (Maintenance Period Month 4)
Average Dose of MIRCERA During Maintenance Period Month 5
Time Frame: Month 9 (Maintenance Period Month 5)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 9 (Maintenance Period Month 5)
Average Dose of MIRCERA During Maintenance Period Month 6
Time Frame: Month 10 (Maintenance Period Month 6)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Month 10 (Maintenance Period Month 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mean Hemoglobin (Hb) Level During Titration Period
Time Frame: Baseline, Month 1, 2, 3, 4
The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.
Baseline, Month 1, 2, 3, 4
The Mean Hemoglobin (Hb) Level During Maintenance Period
Time Frame: Month 5, 6, 7, 8, 9, 10
The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA
Month 5, 6, 7, 8, 9, 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2010

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ML25317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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