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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667380
• Other study ID #: ML25617
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: November 1, 2016
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Montenegro: Agency for Medicines and Medical Devices of Montenegro
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Montenegro, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage/schedule of Mircera treatment in clinical practice		approximately 3 years	No
Secondary	Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment		approximately 3 years	No
Secondary	Change in Hb levels		from baseline to Month 12	No