An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

Completed

• Conditions: Anemia
• Interventions: Drug: Mircera

• Registration Number: NCT01417377
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-31
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2012-03-31
• Study Completion: 2012-03-31
• Results First Submitted: 2015-09-24
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Adult patients, age 18 years or above
• Chronic kidney disease (CKD) with anemia
• Patients on dialysis receiving short-acting epoetin (EPO)
• Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%

Read More

Exclusion Criteria

• Patients unwilling to give informed consent
• Uncontrolled hypertension
• Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
• Relevant acute or chronic bleeding history
• Hemolysis
• Hemoglobinopathies
• Pure red cell aplasia

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Mircera	Mircera

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study	Month 4 up to Month 6

Secondary Outcome Measures

Name	Time	Method
Time to Achieve Hb Level to 11-12 g/dL	Up to 6 months
Number of Dose Adjustments Required to Maintain Hb Levels	Up to 6 months
Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)	Up to 6 months

Trial Locations

Locations (6)

Fatima Memorial Hospital; Nephrology; 🇵🇰 Lahore, Pakistan

Surgimed Hospital; 🇵🇰 Lahore, Pakistan

Sheikh Zayed Hospital; Department of Nephrology; 🇵🇰 Lahore, Pakistan

Northwest General Hospital; Department of Nephrology; 🇵🇰 Peshawar, Pakistan

Doctor's Hospital and Medical Centre; 🇵🇰 Lahore, Pakistan

Khair-un-Nisa Hospital; 🇵🇰 Lahore, Pakistan