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

• Register: CTRI
• Last refreshed on: 10 June 2013
• Main ID: CTRI/2009/091/000452
• Date of registration: 15-10-2010
• Primary sponsor: Roche Products (India) Pvt. Ltd., India
• Public title: 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
• Scientific title: A single arm open label study to assess the efficacy, safety and tolerability of two weekly administration of intravenous MIRCERA for the treatment of chronic renal anaemia in dialysis patients not currently treated with ESA
• Date of first enrolment: 04-07-2008
• Target sample size: 220
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=668
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Centralized Blinding and masking:Open Label

Countries of recruitment

India

Contacts

• Name: Dr. Rupesh Pophale
• Affiliation: Roche Products (India) Pvt. Ltd.

• Name: Dr. Rupesh Pophale
• Affiliation: Roche Products (India) Pvt. Ltd.

Key inclusion & exclusion criteria

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
? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
? Planned (date) elective surgery during the study period


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Chronic Renal Anaemia

Intervention(s)

Intervention1: MIRCERA: 0.6 mcg/kg body weight at the frequency of once in 15 days
Control Intervention1: NIL: NIL

Primary Outcome(s)

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

Secondary Outcome(s)

To evaluate the safety and tolerability of MIRCERA two weekly dosing in the treatment of anaemia in patients with chronic kidney disease.Timepoint: ? Mean change in Hb concentration from baseline (week 0) and last visit (week 16) of the TP

Secondary ID(s)

ML21822

NCT00737711

Source(s) of Monetary Support

Roche Products (India) Pvt. Ltd.