A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

Not Applicable

• Conditions: -D638 Anaemia in other chronic diseases classified elsewhere; Anaemia in other chronic diseases classified elsewhere; D638

• Registration Number: PER-041-08
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Written informed consent
• 18 years of age or older
• Chronic renal anemia
• Hemoglobin concentration> 8.5 g / dL and <10.0 g / dL
• Adequate iron status (serum ferritin> 100 ng / mL OR TSAT> 20% OR hypochromic red blood cells <10%)
• No previous therapy with ESA 3 months before enrollment
• Estimated GFR (eGFR) <60 ml / min and> 20 ml / min

Exclusion Criteria

• Transfusion of red blood cells during the two months before enrollment
• Rapid progression of CKD, that is, a reduction in eGFR of more than 10 mL within the last 3 months
• Poorly controlled hypertension, that is, seated blood pressure exceeding 170/100, despite medication
• Significant chronic or acute bleeding such as obvious gastrointestinal bleeding
• Active malignant disease (except non-melanoma skin cancer)
• Hemolysis: haptoglobin <30 mg / dl (3.54) umol / L) or other reliable positive hemolysis test.
• Hemoglobinopathies (eg, homozygous sickle cell disease, thalassemia of all types).
• Folic acid deficiency, not corrected in the past 2 months judged by local laboratory values, for example, erythrocyte MCV> 105 fL.
• Vitamin B12 deficiency, not corrected in the past 2 months judged by local laboratory values, for example, erythrocyte MOV> 105 fL.
• Platelet count> 500 x 10 9 / L or <100 x 10 9 / L
• Simple (pure) aplasia of red blood cells
• Epilepsy attack during the previous 6 months
• Congestive heart failure (NYHA Class IV)
• Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease at the discretion of the investigator, during the previous 3 months
• Hyperparathyroidism not controlled or secondary by symptoms, PTH> 600
• Pregnancy or lactation period
• Women with pregnancy potential without effective contraception
• Participation in a clinical trial or receipt of a research or treatment compound during the previous 3 months
• Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol, or any other constituent of the study medication.
• Planned elective surgery (date) during the study period, except for: a Cataract surgery b Vascular access surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Measurement of Hb values during the study.<br>Measure:Average change in Hb concentration from the beginning (week 0) and the EPS<br>Timepoints:Key results will be determined in the first 8 weeks after the 24 weeks of the correction period<br>