Phase 3
Completed N=163
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Source: ClinicalTrials.gov NCT00517413 ↗Enrolled (actual)
163
Serious AEs
32.7%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter — 43.7 Percentage of participants
Summary
This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter |
43.7 | — |
| SECONDARY Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP |
0.08 | — |
| SECONDARY Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP |
47.8 | — |
| SECONDARY Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP |
30 | — |
| SECONDARY Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP |
139.6 | — |
| SECONDARY Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP |
65.8; 51.1 | — |
| SECONDARY Mean Monthly Dose of C.E.R.A During the DTP and EEP |
142.5; 139.6 | — |
| SECONDARY Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase |
13 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
120; 53 | — |
| SECONDARY Mean Haemoglobin Levels Over Time |
11.4; 11.7; 11.7; 11.6; 11.5; 11.6 | — |
| SECONDARY Mean Hematocrit Levels Over Time |
0.35; 0.35; 0.36; 0.35; 0.35; 0.35 | — |
| SECONDARY Mean White Blood Cells and Thrombocyte Levels Over Time |
6.8; 6.5; 6.7; 6.6; 6.6; 6.6 | — |
| SECONDARY Mean Phosphate and Potassium Levels Over Time |
1.61; 1.69; 1.70; 1.68; 1.60; 1.59 | — |
| SECONDARY Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time |
847.1; 823.4; 814.0; 822.9; 804.5; 809.7 | — |
| SECONDARY Mean Transferrin Saturation Levels Over Time |
34.7; 39.8; 46.3; 42.1; 39.3; 40.2 | — |
| SECONDARY Mean Albumin and Transferrin Levels Over Time |
39.5; 39.3; 39.3; 39.3; 39.4; 39.9 | — |
| SECONDARY Mean C-Reactive Protein Levels Over Time |
54.1; 87.5; 186.8; 64.0; 53.4; 250.6 | — |
| SECONDARY Mean Ferritin Levels Over Time |
591.8; 617.0; 598.8; 578.5; 583.0; 591.2 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- stable maintenance epoetin alfa therapy for past 2 months.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
- acute or chronic bleeding during previous 2 months.
Data sourced from ClinicalTrials.gov (NCT00517413). 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. Informational only — not medical advice.