A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis

Conditions
-----------------
Anemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; chronic renal anemia; continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose. Exclusion Criteria: transfusion of red blood cells during previous 2 months; poorly controlled hypertension; significant acute or chronic bleeding; active malignant disease (except non-melanoma skin cancer).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>* sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) | The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson. | EEP (Weeks 17 to 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Concentration Between SVP and the EEP | Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24. | SVP (Baseline), and EEP (Weeks 17 to 24) | 
| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP | EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson. | EEP (Weeks 17 to 24) | 
| Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | Weeks 1 to 24 | 
| Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. | Weeks 1 to 24 | 
| Average Dose of Mircera Per Month |  | Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 |