To Study the effect, safety, and tolerability of every 4 weekly administration of subcutaneous Mircera for treating renal anaemia in diabetic nephropathy patients

Phase 4

• Conditions: Health Condition 1: null- Type 2 diabetes mellitus; Chronic kidney disease stages III-IV not on dialysis, not currently treated with ESA.

• Registration Number: CTRI/2010/091/000580
• Lead Sponsor: Roche Products India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Adult patients, greater than equal to 18 years of age

Diabetic nephropathy

Chronic renal anaemia with stage III-IV chronic kidney disease

Not on dialysis and not expected to require dialysis within the next 6 months

Not receiving any erythropoiesis stimulating agent (ESA) in the 2 months prior to study

Adequate iron status

Exclusion Criteria

? Transfusion of red blood cells during the previous 2 months
? Known Folic acid deficiency or MCV > 105 fL
? Known Vitamin B12 deficiency or MCV > 105 fL
? Platelet count >500 x 109/L or <100 x 109/L
? Known or clinical suspicion of pure red call aplasia (PRCA)
? Pregnancy or lactation period and women of childbearing potential without effective contraception
? Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months
? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
? Disease states like: Significant acute or chronic bleeding, Hemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types), Uncontrolled or symptomatic secondary hyperparathyroidism, Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100mm Hg, poorly controlled diabetes (HbA1C > 9 % ) Epileptic seizure during previous 6 months, Myocardial infarction or stroke, severe or unstable CAD, Severe liver disease, Congestive heart failure (NYHA Class III-IV) during the previous 3 months.
? Patient with significant change (> or = 50%) in the dose of Thiazolidinediones (TZD) in previous 2 months.
? Planned (date) elective surgery during the study period except for cataract surgery and vascular access surgery
? Any other concomitant conditions which as per investigators opinion may affect patient?s interest and compliance to this protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean time to achieve target Hemoglobin (10-12g/dL) <br/ ><br>Mean change in Hemoglobin concentration from baseline to end of efficacy evaluation period (EEP) <br/ ><br>Proportion of patients in the target Hemoglobin range (10-12 g/dl) at EEPTimepoint: Time Frame: from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Safety endpoints <br/ ><br>Incidence of Adverse Events during the study <br/ ><br>Changes and abnormalities in laboratory safety parameters <br/ ><br>The incidence of red blood cell transfusions during the C.E.R.A. treatment phase <br/ ><br>Reports of anti-epoetin antibodies, if any <br/ ><br>Timepoint: Time Frame: 28 weeks