An observational study in Kidney Disease, Chronic, sponsored by Hoffmann-La Roche. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-05.
Sponsored by Hoffmann-La Roche · Observational
This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 340 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with chronic kidney disease receiving Mircera treatment
Exclusion Criteria:
Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.
Average Dose of MIRCERA at Entry Level
The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Time frame: Baseline
Average Dose of MIRCERA During Titration Period Month 1
The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Time frame: Month 1
Average Dose of MIRCERA During Titration Period Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Time frame: Month 2
Average Dose of MIRCERA During Titration Period Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Time frame: Month 3
Average Dose of MIRCERA During Titration Period Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Time frame: Month 4
Average Dose of MIRCERA During Maintenance Period Month 1
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 5 (Maintenance Period Month 1)
Average Dose of MIRCERA During Maintenance Period Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 6 (Maintenance Period Month 2)
Average Dose of MIRCERA During Maintenance Period Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 7 (Maintenance Period Month 3)
Average Dose of MIRCERA During Maintenance Period Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 8 (Maintenance Period Month 4)
Average Dose of MIRCERA During Maintenance Period Month 5
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 9 (Maintenance Period Month 5)
Average Dose of MIRCERA During Maintenance Period Month 6
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Time frame: Month 10 (Maintenance Period Month 6)
The Mean Hemoglobin (Hb) Level During Titration Period
The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.
Time frame: Baseline, Month 1, 2, 3, 4
The Mean Hemoglobin (Hb) Level During Maintenance Period
The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA
Time frame: Month 5, 6, 7, 8, 9, 10
| Milestone | Chronic Kidney Disease (CKD) |
|---|---|
| Started | 340 |
| Completed | 340 |
| Not completed | 0 |
| Milestone | Chronic Kidney Disease (CKD) |
|---|---|
| Started | 340 |
| Completed | 329 |
| Not completed | 11 |
| Withdrew: Death | 2 |
| Withdrew: Protocol violation | 9 |
The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA at Entry Level | 94 ± 49 |
The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.
| g/L | Chronic Kidney Disease (CKD) |
|---|---|
| Baseline | 93.9 ± 11.7 |
| Month 1 | 98.4 ± 12.4 |
| Month 2 | 103.4 ± 12.7 |
| Month 3 | 106.3 ± 12.0 |
| Month 4 | 108.4 ± 12.4 |
The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA
| g/L | Chronic Kidney Disease (CKD) |
|---|---|
| Month 5 | 109.3 ± 11.6 |
| Month 6 | 110.3 ± 10.3 |
| Month 7 | 111.2 ± 9.8 |
| Month 8 | 112.1 ± 10.3 |
| Month 9 | 112.5 ± 10.9 |
| Month 10 | 113.8 ± 10.9 |
The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Titration Period Month 1 | 101.3 ± 54 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Titration Period Month 2 | 102.4 ± 54.3 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Titration Period Month 3 | 106.1 ± 56.2 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Titration Period Month 4 | 107.5 ± 59.8 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 1 | 105 ± 61 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 2 | 106 ± 61.7 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 3 | 107 ± 63.6 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 4 | 109 ± 66.5 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 5 | 112 ± 66.2 |
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
| microgram (µg) | Chronic Kidney Disease (CKD) |
|---|---|
| Average Dose of MIRCERA During Maintenance Period Month 6 | 114 ± 65.9 |
Collected over 3.5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Kidney Disease (CKD) | — | 5/340 (1.5%) | 2/340 (0.6%) |
| Event | Chronic Kidney Disease (CKD) |
|---|---|
| Cardiac failure leftCardiac disorders | 1/340 |
| SepsisInfections and infestations | 1/340 |
| Endocarditis infectiveInfections and infestations | 1/340 |
| Peripheral arterial diseaseVascular disorders | 1/340 |
| Post surgical haemorrhageInjury, poisoning and procedural complications | 1/340 |
| SurgerySurgical and medical procedures | 1/340 |
| Event | Chronic Kidney Disease (CKD) |
|---|---|
| HeadacheNervous system disorders | 2/340 |
All enrolled participants were included.
| Age, Continuous(years) | Chronic Kidney Disease (CKD) |
|---|---|
| Mean | 62.4 ± 14.6 |
| Sex: Female, Male(Participants) | Chronic Kidney Disease (CKD) |
|---|---|
| Female | 172 |
| Male | 168 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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