A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

Study Overview
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Brief Summary
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This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin 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 500+ individuals.

Official Title
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An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; chronic renal anemia; longterm hemodialysis for >=12 weeks before screening; baseline Hb between 10 and 13g/dL; iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening. Exclusion Criteria: acute or chronic bleeding within 8 weeks prior to screening; transfusion of red blood cells within 8 weeks prior to screening; poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months; previous treatment with Mircera.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase |  | Visits 8 to 10 (Months 6 to 8) | 
| Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase |  | Visits 8 to 10 (Months 6 to 8) | 
| Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase | Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. | Visits 8 to 10 (Months 6 to 8) | 
| Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase | Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. | Visits 8 to 10 (Months 6 to 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase |  | Visits 1 to 2 (Months -2 to -1) | 
| Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase |  | Visits 1 to 2 (Months -2 to -1) | 
| Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase | Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. | Visits 1 to 2 (Months -2 to -1) | 
| Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase | Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported. | Visits 1 to 2 (Months -2 to -1) | 
| Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels | Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase. Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted. | Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8) | 
| Percentage of Participants With Hb Fluctuations Within Evaluation Phase | Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study. | Visits 8 to 10 (Months 6 to 8) | 
| Percentage of Participants With Hb Fluctuations Within Screening Phase | Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study. | Visits 1 to 2 (Months -2 to -1) | 
| Percentage of Participants Requiring Erythrocyte Transfusions |  | Visits 1 to 10 (Months -2 to 8) |