LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

A Single-Arm Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-040-07

Enrollment

Registered

2007-10-15

Start date

2006-12-26

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

ONLY GROUP Type of group

All patients in this study will be treated with CERA, in sterile injectables, available in pre-filled syringes of 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 ug each in 0.3 mL of solution, or 400 ug in 0.6 mL of solution. The initial dose will vary, being 120, 200 or 360 ug, depending on the dose of Erythropoietin alfa, previously administered to the patient,. Each dose will be administered monthly, IV or SC. The doses may be adjusted according to clinical criteria, for 16 weeks (dose graduati

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. Age 18 years or older. 3. Chronic renal anemia. 4. Concentration of hemoglobin between 10.5 and 12.5 g / dl. 5. Suitable iron status. 6. Continuous maintenance therapy with intravenous and / or subcutaneous erythropoietin alfa with the same dosing interval during the last 2 months. 7. Regular therapy with hemodialysis or long-term peritoneal dialysis with the same mode of dialysis for a minimum of 3 months prior. 8. Kt / V ≥ 1.2 in the selection for hemodialysis patients. 9. Kt / V ≥ 1.8 in the selection for patients with peritoneal dialysis.

Exclusion criteria

Exclusion criteria: 1. Transfusion of erythrocytes during the previous 2 months. 2. Deficiently controlled hypertension. 3. Acute or chronic heavy bleeding. 4. Active malignant disease. 5. Hemolysis: haptoglobin 500 x 10-9 / L. 10. Pure aplasia of the red series. 11. Epileptic seizures during the previous 6 months. 12. C Reactive Protein (CRP)> 30 mg / L. 13. Congestive heart failure (NYHA Class IV). 14. Myocardial infarction or cerebrovascular accident, severe or unstable coronary disease, severe liver disease at the discretion of the investigator, during the previous 3 months. 15. Non-controlled or symptomatic secondary hyperparathyroidism. 16. Pregnancy or lactation period. 17. Potentially fertile women without effective contraception. 18. Participation in a clinical study or reception of an experimental compound or experimental treatment during the previous 3 months. 19. Unknown hypersensitivity to human recombinant erythropoietin, polyethylene glycol or any component of the study drug. 20. Elective surgery planned during the study period except for cataract surgery. 21. Temporary catheter for dialysis access.

Design outcomes

Primary

Measure	Time frame
Outcome name:Serum levels of Hemoglobin. Measure:Proportion of patients maintaining their average hemoglobin concentration (g / dl) within ± 1 g / dl with respect to their reference Hb between 10.5 and 12.5 g / dl. Timepoints:Weeks 16 and 24.	—

Secondary

Measure	Time frame
Outcome name:Serum levels of Hemoglobin. Measure:1) Change in hemoglobin concentration between the Stability Verification Period (SVP) and the Efficacy Assessment Period (EPS). 2) Proportion of patients maintaining a hemoglobin concentration within the hemoglobin range of 10.5-12.5 g / dL throughout the EPS. 3) Average time used in the hemoglobin range of 10.5-12.5 g / dL. Timepoints:Criterion 1 and 2: Between weeks 4 and 8. Criterion 3: Weeks 0, 1, 2 and every 2 weeks up to week 48. ; Outcome name:Determination of the number of patients who, due to clinical criteria, required a dose adjustment of the study drug or a transfusion of erythrocytes. Measure:Secondary efficacy: 1) Proportion of patients requiring any dose adjustment. 2) Incidence of erythrocyte transfusions. Timepoints:Between weeks 8 and 16. ; Outcome name:Criteria 1 and 2: Clinical evaluation of any undesirable event in a patient to whom the investigational medication is administered. Criterion 3: Panels of hematology and serum chemistry. Criterion 4: Serum levels of anti-erythropoietin antibodies. Criterion 5: Counting of patients who required erythrocyte transfusion. Measure:Security: 1) General incidence of adverse events. 2) Number, severity, frequency, duration of individual events. 3) Changes and anomalies in laboratory safety parameters. 4) Reports of anti-erythropoietin antibodies. 5) Incidence of erythrocyte transfusions. Timepoints:Criteria 1, 2 and 5: When the event is presented. Criterion 3: Weeks -4, 8, 16, 24,232, 38 and 48. Criterion 4: Weeks 0 and 48.	—

Measure

Time frame

Outcome name:Serum levels of Hemoglobin. Measure:1) Change in hemoglobin concentration between the Stability Verification Period (SVP) and the Efficacy Assessment Period (EPS). 2) Proportion of patients maintaining a hemoglobin concentration within the hemoglobin range of 10.5-12.5 g / dL throughout the EPS. 3) Average time used in the hemoglobin range of 10.5-12.5 g / dL. Timepoints:Criterion 1 and 2: Between weeks 4 and 8. Criterion 3: Weeks 0, 1, 2 and every 2 weeks up to week 48. ; Outcome name:Determination of the number of patients who, due to clinical criteria, required a dose adjustment of the study drug or a transfusion of erythrocytes. Measure:Secondary efficacy: 1) Proportion of patients requiring any dose adjustment. 2) Incidence of erythrocyte transfusions. Timepoints:Between weeks 8 and 16. ; Outcome name:Criteria 1 and 2: Clinical evaluation of any undesirable event in a patient to whom the investigational medication is administered. Criterion 3: Panels of hematology and serum chemistry. Criterion 4: Serum levels of anti-erythropoietin antibodies. Criterion 5: Counting of patients who required erythrocyte transfusion. Measure:Security: 1) General incidence of adverse events. 2) Number, severity, frequency, duration of individual events. 3) Changes and anomalies in laboratory safety parameters. 4) Reports of anti-erythropoietin antibodies. 5) Incidence of erythrocyte transfusions. Timepoints:Criteria 1, 2 and 5: When the event is presented. Criterion 3: Weeks -4, 8, 16, 24,232, 38 and 48. Criterion 4: Weeks 0 and 48.

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Contacts

Public ContactLeslie Kikushima

PRODUCTOS ROCHE Q.F.S.A.

pilar.kikushima@roche.com997555937

Outcome results