A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

Study Overview
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Brief Summary
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This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.

Official Title
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Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients

Conditions
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Anemia, Kidney Disease, Chronic

Intervention / Treatment
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* Drug: Methoxy polyethylene glycol-epoetin beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Chronic kidney disease stage III-IV or V Probable start of dialysis within 18 months (pre-dialysis group) Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group) Adequate iron status Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug 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, defined as hypertension that needs hospitalization to obtain control History of seizures, hemoglobinopathies and/or severe liver disease Active malignant disease, except for non-melanoma skin cancer Immunosuppressive therapy in the 12 weeks prior to screening Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients Pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-dialysis, sea level<br>Participants received 50-250 mcg SC according to local label. | Drug: Methoxy polyethylene glycol-epoetin beta<br>* Participants received 50-250 mcg SC according to local label<br>* Other names: Mircera;|
| Active Comparator: Dialysis, sea level<br>Participants received 50-250 mcg SC according to local label. | Drug: Methoxy polyethylene glycol-epoetin beta<br>* Participants received 50-250 mcg SC according to local label<br>* Other names: Mircera;|
| Experimental: Pre-dialysis, >1800 meters<br>Participants received 50-250 mcg SC according to local label. | Drug: Methoxy polyethylene glycol-epoetin beta<br>* Participants received 50-250 mcg SC according to local label<br>* Other names: Mircera;|
| Experimental: Dialysis, >1800 meters<br>Participants received 50-250 mcg SC according to local label. | Drug: Methoxy polyethylene glycol-epoetin beta<br>* Participants received 50-250 mcg SC according to local label<br>* Other names: Mircera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL |  | Up to approximately 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Concentration |  | From baseline to 6 months | 
| Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment |  | 3 and 6 months | 
| Percentage of Participants With Adverse Events | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | Up to approximately 20 months | 
| Percentage of Participants Requiring Dose Adjustments | This outcome measure was not assessed. | Up to approximately 20 months | 
| Incidence of Red Blood Cell Transfusions | This outcome measure was not assessed. | Up to approximately 20 months |