CompletedNot Applicable

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

Sweden144 participantsStarted 2009-04

Plain-language summary

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.

Who can participate

Age range

18 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: * 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.

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 Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion

Timeframe: Pre-baseline (Month -6)

Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion

Timeframe: Pre-baseline (Month -3)

Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline

Timeframe: Baseline

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion

Timeframe: Month 3

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion

Timeframe: Month 6

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion

Timeframe: Month 9

Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion

Trial details

NCT IDNCT02567188

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-04

Results submitted2015-11-02

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