N/A
N=144
A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT02567188 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: 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 — 56.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MIRCERA (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
56.8 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion |
56.0 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline |
42.4 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion |
41.0 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion |
41.6 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion |
33.0 | — |
| PRIMARY Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion |
45.5 | — |
| PRIMARY Mean Hb Value at Month 6 Before Inclusion |
113.2 | — |
| PRIMARY Mean Hb Value at Month 3 Before Inclusion |
112.6 | — |
| PRIMARY Mean Hb Value at Baseline |
117.5 | — |
| PRIMARY Mean Hb Value at Month 3 After Inclusion |
120.2 | — |
| PRIMARY Mean Hb Value at Month 6 After Inclusion |
120.0 | — |
| PRIMARY Mean Hb Value at Month 9 After Inclusion |
120.0 | — |
| PRIMARY Mean Hb Value at Month 12 After Inclusion |
118.4 | — |
| PRIMARY Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline |
36.5 | — |
| PRIMARY Percentage of Participants With Hb Fluctuation From Baseline to Month 12 |
43.6 | — |
| SECONDARY Percentage of Participants With Change in MIRCERA Treatment |
43.1; 30.8; 22.7; 23.2 | — |
| SECONDARY Percentage of Participants With Number of MIRCERA Dose Changes |
26.4; 41.8; 17.6; 13.2; 1.1 | — |
| SECONDARY Correlation of Hb Levels With Underlying Disease |
— | — |
| SECONDARY Correlation of Hb Levels With Levels of Inflammation |
— | — |
| SECONDARY Percentage of Participants With Changes in Iron Supplement |
31.3; 12.8; 15.5; 11.5; 13.0; 9.2 | — |
| SECONDARY Percentage of Participants With Changes in Immunosuppressive Treatment |
23.0; 4.0; 5.6; 8.5; 8.8; 2.8 | — |
| SECONDARY Percentage of Participants With Changes in Antihypertensive Treatment |
78.5; 22.4; 22.7; 12.3; 13.0; 16.5 | — |
| SECONDARY Number of Participants With Different Medication Treatment |
123; 35; 71; 55 | — |
| SECONDARY Percentage of Participants Who Required Blood Transfusion |
0; 2.3; 5.6; 1.5; 1.7; 3.7 | — |
| SECONDARY Percentage of Participants Who Required Renal Replacement Therapy |
0.8; 0.9; 0.9; 1.8; 0.8; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02567188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.