A clinical trial to assess the effect, safety and tolerability of MIRCERA administered intravenously or subcutaneously once in a month for the maintainance of Haemoglobin levels in dialysis patients with chronic renal anaemia

Phase 4

• Conditions: Chronic Renal Anaemia

• Registration Number: CTRI/2009/091/000455
• Lead Sponsor: Roche Products (India) Pvt.Ltd, India

Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

• Written informed consent?
• Age 18 years or older?
• Chronic renal anaemia?
• Haemoglobin concentration between 10.0 g/dl and 12.0 g/dL?
• Adequate iron status as judged by Investigator ?
• Continuous intravenous or subcutaneous maintenance epoetin alfa therapy with the same dosing interval during the previous 2 months?
• Regular long-term haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 2 months.

Exclusion Criteria

• Blood transfusion during the previous 1 month?
• Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication requiring hospitalization or interruption of epoetin alfa treatment in the previous 2 months?
• Significant acute or chronic bleeding such as overt gastrointestinal bleeding?
• Medically significant dialysis inadequacy?
• Known malignant disease (except non-melanoma skin cancer)?
• Known 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?
• Known Folic acid deficiency (uncorrected in past 2 months)?
• Known 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 the maintenance of haemoglobin levels, with once-monthly intravenous or subcutaneous administration of MIRCERA in dialysis patients with chronic renal anaemia.	?The proportion of patients maintaining mean haemoglobin concentration during last 4 weeks of Treatment Period (TP) within the target range i.e. 10.0 ? 12.0g/dL.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of MIRCERA once monthly in the treatment of anaemia in dialysis patients with chronic kidney disease	? Change in mean haemoglobin concentration between reference (SVP) and in last 4 weeks of Treatment Period (TP)? Mean time spent in haemoglobin range of 10.0 -12.0 g/dL

Trial Locations

Locations (15)

Apex Kidney Care; 🇮🇳 Mumbai, MAHARASHTRA, India

Fortis Flt. Lt. Rajan Dhall Hospital,; 🇮🇳 Delhi, DELHI, India

Indraprastha Apollo Hospitals; 🇮🇳 Delhi, DELHI, India

International Hospital; 🇮🇳 Tower,, India

Kamineni Hospitals Limited; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

KANTI Columbia Asia Medical Centre; 🇮🇳 Bangalore, KARNATAKA, India

Lancelot dialysis Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Madras Medical Mission Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Manipal Institute of Nephrology & Urology,; 🇮🇳 Bangalore, KARNATAKA, India

Meerut kidney hospital Pvt. Ltd; 🇮🇳 Meerut, UTTAR PRADESH, India

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Apex Kidney Care

🇮🇳Mumbai, MAHARASHTRA, India

Dr Shrirang Bichu/Dr Prakash Jadhav

Principal investigator

drprjadhav@yahoo.com