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: April 7, 2014
Last verified: April 2014
  Purpose

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.


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
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: April 7, 2014
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014