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

NCT02567188 | Completed Results

• 1 other identifier: ML22439
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (10)

• Percentage of Participants With Change in MIRCERA Treatment

  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

  Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12

Study Arms (1)

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

Interventions

MIRCERA OTHER

Cohort of CKD Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with CKD Stage 3-4 treated with MIRCERA

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

Unknown Facility

Angeholm, S-262 81, Sweden

Location

Unknown Facility

Bollnäs, 821 81, Sweden

Location

Unknown Facility

Eskilstuna, 63188, Sweden

Location

Unknown Facility

Gävle, 80187, Sweden

Location

Unknown Facility

Gothenburg, 41345, Sweden

Location

Unknown Facility

Gothenburg, S-402 76, Sweden

Location

Unknown Facility

Huddinge, 14186, Sweden

Location

Unknown Facility

Jönköping, 55185, Sweden

Location

Unknown Facility

Karlshamn, S-374 80, Sweden

Location

Unknown Facility

Karlstad, 65185, Sweden

Location

Unknown Facility

Kristianstad, 29185, Sweden

Location

Unknown Facility

Linköping, S-581 85, Sweden

Location

Unknown Facility

Mölndal, S-431 80, Sweden

Location

Unknown Facility

Norrköping, 60182, Sweden

Location

Unknown Facility

Skövde, 54185, Sweden

Location

Unknown Facility

Stockholm, 17176, Sweden

Location

Unknown Facility

Stockholm, 18288, Sweden

Location

Unknown Facility

Umeå, 90185, Sweden

Location

Unknown Facility

Värnamo, 33185, Sweden

Location

Unknown Facility

Västervik, 59381, Sweden

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 2, 2015
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 11, 2025
• Results First Posted: December 30, 2015

Record last verified: 2025-08

Locations

SE (20)