CompletedNot Applicable

An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

Slovenia393 participantsStarted 2008-12-31

Plain-language summary

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants aged \> 18 years with CKD * Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC) Exclusion Criteria: * Non-renal anemia * Pregnancy and breast-feeding * Uncontrolled hypertension * Known hypersensitivity to methoxy polyethylene glycol-epoetin beta * Administration of any other study drug within 30 days prior to study enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline

Timeframe: Baseline

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3

Timeframe: At Months 1-3

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6

Timeframe: At Months 4-6

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9

Timeframe: At Months 7-9

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12

Timeframe: At Months 10-12

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15

Timeframe: At Months 13-15

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18

Trial details

NCT IDNCT02547454

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-11-30

Results submitted2015-10-21

View on ClinicalTrials.gov More Kidney Disease, Chronic trials