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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: November 4, 2015
Last verified: November 2015
  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 Intervention
Anemia
Drug: Mircera

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 Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study [ Time Frame: Month 4 up to Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Achieve Hb Level to 11-12 g/dL [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of Dose Adjustments Required to Maintain Hb Levels [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Mircera
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, 54590
Lahore, Pakistan
Peshawar, Pakistan
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01417377     History of Changes
Other Study ID Numbers: ML25368 
Study First Received: August 5, 2011
Results First Received: September 24, 2015
Last Updated: November 4, 2015
Health Authority: Pakistan: Ministry of Health

ClinicalTrials.gov processed this record on September 30, 2016