A Clinical Trial to assess the effect, safety and tolerability of MIRCERA administered intravenously two weekly for treating the chronic renal anaemia in dialysis patients who are not receiving ESA treatment currently

Phase 4

Completed

• Conditions: Chronic Renal Anaemia

• Registration Number: CTRI/2009/091/000452
• Lead Sponsor: Roche Products India Pvt Ltd India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-07
• Last Update Posted: 2016-05-08

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

• Written informed consent?
• Age 18 years or older?
• Chronic renal anaemia?
• Haemoglobin concentration between 8 g/dL and 10 g/dL?
• No prior ESA therapy during the previous 2 months?
• Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%) ?
• Haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 4 Weeks.

Exclusion Criteria

• Blood transfusion during the previous 4 Weeks?
• Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication.
• Average of 2 values measured at least two hours apart before dialysis ?
• Significant acute or chronic bleeding such as overt gastrointestinal bleeding?
• Active malignant disease (except non-melanoma skin cancer)?
• History of Haemolysis ?
• History of Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)?
• Platelet count >500 x 109/L or <100 x 109/L ?
• History of Pure red cell aplasia?
• Folic acid deficiency, uncorrected in past 2 months?
• Vitamin B12 deficiency, uncorrected in past 2 months?
• Epileptic seizure during previous 6 months ?
• Congestive heart failure (NYHA Class IV)?
• Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months?
• Pregnancy or lactation period?
• 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?
• Planned (date) elective surgery during the study period.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess effectiveness of two-weekly intravenous administration of MIRCERA in dialysis patients with chronic renal anaemia, not currently treated with ESA.	? Mean change in Hb concentration from baseline (week 0) and last visit (week 16) of the TP

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of MIRCERA two weekly dosing in the treatment of anaemia in patients with chronic kidney disease.	? Time to achievement of response (achievement of Hb levels within target range i.e. 10.0 ? 12.0 g/dL)? The percentage of patients whose average Hb concentration is within the range 10.0 ? 12.0 g/dL in the last 4 weeks of TP? Mean time spent in Hb range of 10.0 ? 12.0 g/dL during the last 4 weeks of TP

Trial Locations

Locations (16)

Anil Clinic; 🇮🇳 India

Armenian Church Trauma Center; 🇮🇳 India

Chettinad Hospital And Research Institute; 🇮🇳 India

Christian Medical College; 🇮🇳 India

Deep Kidney Care,; 🇮🇳 Ludhiana, PUNJAB, India

Gujrat Kidney Foundation; 🇮🇳 India

Jaslok Hospital and Research Center; 🇮🇳 India

King George Hospital; 🇮🇳 India

Kovai Medical Center and Hospital; 🇮🇳 India

Maharaja Agrasain Hospital; 🇮🇳 India

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Anil Clinic

🇮🇳India

Dr. Bharat Shah

Principal investigator