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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 5, 2011
Last updated: March 2, 2015
Last verified: March 2015

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining Hb levels between 11-12 g/dL during final 2 months of study (assessment period) [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achieve Hb level to 11-12 g/dL [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Number of dose adjustments [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Dosage/schedule in clinical practice [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic kidney disease


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01417377

Lahore, Pakistan, 20021
Lahore, Pakistan
Lahore, Pakistan, 54590
Peshawar, Pakistan
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01417377     History of Changes
Other Study ID Numbers: ML25368
Study First Received: August 5, 2011
Last Updated: March 2, 2015
Health Authority: Pakistan: Ministry of Health processed this record on March 25, 2015