A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

NCT ID: NCT02567188

Last Updated: 2025-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-04-30

Brief Summary

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An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.

Detailed Description

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Conditions

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Anemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort of CKD Participants

Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.

MIRCERA

Intervention Type OTHER

Interventions

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MIRCERA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult participants above 18 years of age
* Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
* Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Exclusion Criteria

* Participants involved in interventional trials
* Participants with life expectancy less than 1 year
* Active malignancy
* Planned living kidney transplant within 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Angeholm, , Sweden

Site Status

Bollnäs, , Sweden

Site Status

Eskilstuna, , Sweden

Site Status

Gävle, , Sweden

Site Status

Gothenburg, , Sweden

Site Status

Gothenburg, , Sweden

Site Status

Huddinge, , Sweden

Site Status

Jönköping, , Sweden

Site Status

Karlshamn, , Sweden

Site Status

Karlstad, , Sweden

Site Status

Kristianstad, , Sweden

Site Status

Linköping, , Sweden

Site Status

Mölndal, , Sweden

Site Status

Norrköping, , Sweden

Site Status

Skövde, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Umeå, , Sweden

Site Status

Värnamo, , Sweden

Site Status

Västervik, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ML22439

Identifier Type: -

Identifier Source: org_study_id

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