A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.

Official Title
-----------------
A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic nephropathy Chronic renal anemia with stage III-IV CKD Not on dialysis and not expected to require dialysis within the next 6 months Not receiving any ESA in the 2 months prior to study Adequate iron status Exclusion Criteria: Transfusion of red blood cells during the previous 2 months Known or clinical suspicion of pure red cell aplasia Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication Haemoglobinopathy Significant acute or chronic bleeding

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: Methoxy polyethylene glycol-epoetin beta<br>Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W. | Drug: Methoxy polyethylene glycol-epoetin beta [Mircera]<br>* Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W<br>* Other names: Mircera, C.E.R.A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP) |  | EEP (Week 17 up to Week 24) | 
| Change in Hb Concentration Between Baseline and EEP |  | Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24) | 
| Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP |  | EEP: (Week 17 up to Week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events |  | Baseline (Week -2 up to Week 0) to Week 28 | 
| Percentage of Participants With Red Blood Cell Transfusion During Treatment Period |  | Week 0 up to Week 24 | 
| Percentage of Participants with anti-epoetin antibodies |  | Baseline (Week-2 up to Week 0) up to Week 28 | 
| Short Form-36 Health Survey (SF-36) score |  | Week 0 to Week 24 |