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An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667380
First received: August 13, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.


Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dosage/schedule of Mircera treatment in clinical practice [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Change in Hb levels [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
  • Patients with chronic renal anemia with stage V CKD on dialysis
  • No contraindication to ESA treatment

Exclusion Criteria:

  • Uncontrolled hypertension
  • Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667380

Contacts
Contact: Please reference Study ID Number: ML25617 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Montenegro
Recruiting
Podgorica, Montenegro, 81 000
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: NCT01667380     History of Changes
Other Study ID Numbers: ML25617
Study First Received: August 13, 2012
Last Updated: May 7, 2013
Health Authority: Montenegro: Agency for Medicines and Medical Devices of Montenegro

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

ClinicalTrials.gov processed this record on May 19, 2013