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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Other: MIRCERA

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Sweden
  • Angeholm, Sweden, S-262 81
  • Bollnas, Sweden, 821 81
  • Eskilstuna, Sweden, 63188
  • Gaevle, Sweden, 80187
  • Goeteborg, Sweden, 41345
  • Gothenburg, Sweden, S-402 76
  • Huddinge, Sweden, 14186
  • Jonkoping, Sweden, 55185
  • Karlshamn, Sweden, S-374 80
  • Karlstad, Sweden, 65185
  • Kristianstad, Sweden, 29185
  • Linkoeping, Sweden, S-581 85
  • Mölndal, Sweden, S-431 80
  • Norrkoeping, Sweden, 60182
  • Skövde, Sweden, 54185
  • Stockholm, Sweden, 17176
  • Stockholm, Sweden, 18288
  • Umea, Sweden, 90185
  • Värnamo, Sweden, 33185
  • Västervik, Sweden, 59381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with CKD Stage 3-4 treated with MIRCERA

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: MIRCERA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		Pre-baseline (Month -6)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion		Pre-baseline (Month -3)
Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline		Baseline
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion		Month 3
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion		Month 6
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion		Month 9
Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion		Month 12
Mean Hb Value at Month 6 Before Inclusion		Pre-baseline (Month -6)
Mean Hb Value at Month 3 Before Inclusion		Pre-baseline (Month -3)
Mean Hb Value at Baseline		Baseline
Mean Hb Value at Month 3 After Inclusion		Month 3
Mean Hb Value at Month 6 After Inclusion		Month 6
Mean Hb Value at Month 9 After Inclusion		Month 9
Mean Hb Value at Month 12 After Inclusion		Month 12
Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline	Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.	Pre-baseline (Month -6) to Baseline
Percentage of Participants With Hb Fluctuation From Baseline to Month 12	Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.	Baseline to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Change in MIRCERA Treatment	Change in MIRCERA treatment included changes in dose, frequency, and route of administration.	Months 3, 6, 9, and 12
Percentage of Participants With Number of MIRCERA Dose Changes		Baseline to Month 12
Correlation of Hb Levels With Underlying Disease		Baseline to 12 months
Correlation of Hb Levels With Levels of Inflammation		Baseline to 12 months
Percentage of Participants With Changes in Iron Supplement	Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in Immunosuppressive Treatment	Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants With Changes in AntihypertensiveTreatment	Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.	Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Number of Participants With Different Medication Treatment	Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.	Pre-baseline (Month -6) to Month 12
Percentage of Participants Who Required Blood Transfusion		Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12
Percentage of Participants Who Required Renal Replacement Therapy	Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.	Months 3, 6, 9, and 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ML22439