A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Official Title
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A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta
* Drug: epoetin alfa
* Drug: darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; chronic kidney disease stage IV not requiring dialysis; expected to initiate dialysis within 18 months; 15<=Glomerular Filtration Rate (GFR)<=29. Exclusion Criteria: failing renal allograft in place; acute or chronic bleeding within 8 weeks prior to screening; transfusion of red blood cells within 8 weeks prior to screening; poorly controlled hypertension; immunosuppressive therapy in the 12 weeks prior to screening.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methoxy polyethylene glycol-epoetin beta<br>120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | Drug: methoxy polyethylene glycol-epoetin beta<br>* Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.<br>* Other names: Mircera;|
| Active Comparator: Epoetin alfa<br>Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | Drug: epoetin alfa<br>* Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.<br>|
| Active Comparator: Darbepoetin alfa<br>Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. | Drug: darbepoetin alfa<br>* Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL | Efficacy analyses were not performed. | 6-7 months post initiation of dialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Adjustments | Efficacy analyses were not performed. | 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end. | 
| Number of Participants Assessed for AEs and SAEs | The adverse events are captured in the adverse event and serious adverse event section of this database. | First dose of medication through 15 days post last dose (up to 8 months) |