A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

Study Overview
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Brief Summary
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This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

Official Title
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A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Conditions
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Anemia

Intervention / Treatment
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* Procedure: Dialysis
* 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 anaemia haemoglobin 10.0-12.0g/dl at screening adequate iron status continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months regular haemodialysis or regular peritoneal dialysis for >/= 3 months Exclusion Criteria: uncontrolled hypertension haemoglobinopathy anaemia due to haemolysis pure red cell aplasia (PRCA)

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: Single Arm<br> | Procedure: Dialysis<br>* regular haemodialysis or peritoneal dialysis<br>Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* once monthly, subcutaneously or intravenously, for 32 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported. | Weeks 1 to 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Monthly Hb Values | The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 | 
| Change in Hb Concentration Between Reference and Treatment Period | The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 | 
| Mean Time Participants Spent Having Hb Concentration Within Target Range | Target Hb concentration was between 10.0 and 12.0 g/dL. | Weeks 1 to 32 | 
| Percentage of Participants Requiring Dose Adjustments | Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm. | Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8 |