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 range18 Years

SexALL

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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.

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

Timeframe: Month 12

Trial details

NCT IDNCT02567188

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-04

Results submitted2015-11-02

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