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

Anemia Clinical Trial

Official title:

Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417377
• Other study ID #: ML25368
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: November 4, 2015
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Mircera
Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Achieve Hb Level to 11-12 g/dL		Up to 6 months	No
Secondary	Number of Dose Adjustments Required to Maintain Hb Levels		Up to 6 months	No
Secondary	Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)		Up to 6 months	No