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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01417377
First received: August 5, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition
Anemia

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)

Resource links provided by NLM:


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)

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01417377

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01417377     History of Changes
Other Study ID Numbers: ML25368
Study First Received: August 5, 2011
Last Updated: August 4, 2014
Health Authority: Pakistan: Ministry of Health

ClinicalTrials.gov processed this record on September 22, 2014