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

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567188
• Other study ID #: ML22439
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: January 14, 2016
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden:Swedish Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• MIRCERA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion		Pre-baseline (Month -3)	No
Primary	Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline		Baseline	No
Primary	Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion		Month 3	No
Primary	Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion		Month 6	No
Primary	Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion		Month 9	No
Primary	Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion		Month 12	No
Primary	Mean Hb Value at Month 6 Before Inclusion		Pre-baseline (Month -6)	No
Primary	Mean Hb Value at Month 3 Before Inclusion		Pre-baseline (Month -3)	No
Primary	Mean Hb Value at Baseline		Baseline	No
Primary	Mean Hb Value at Month 3 After Inclusion		Month 3	No
Primary	Mean Hb Value at Month 6 After Inclusion		Month 6	No
Primary	Mean Hb Value at Month 9 After Inclusion		Month 9	No
Primary	Mean Hb Value at Month 12 After Inclusion		Month 12	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Percentage of Participants With Number of MIRCERA Dose Changes		Baseline to Month 12	No
Secondary	Correlation of Hb Levels With Underlying Disease		Baseline to 12 months	No
Secondary	Correlation of Hb Levels With Levels of Inflammation		Baseline to 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Who Required Blood Transfusion		Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12	No
Secondary	Percentage of Participants Who Required Renal Replacement Therapy	Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.	Months 3, 6, 9, and 12	No