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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667380
First received: August 13, 2012
Last updated: July 7, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 78
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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
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: NCT01667380

Locations
Montenegro
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: July 7, 2014
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 July 20, 2014