An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

Anemia Clinical Trial

Official title:

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695746
• Other study ID #: ML25476
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: November 2, 2015
• Start date: August 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drug Controller General
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18 to 65 years of age, inclusive

• Patients with stage III-IV chronic kidney disease not on dialysis

• ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL

• Adequate iron status as judged by the treating physician

Exclusion Criteria:

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

• Clinically significant concomitant disease or disorder as defined by protocol

• Clinical suspicion of pure red cell aplasia (PRCA)

• Planned elective surgery during the study period , except for cataract surgery or vascular access surgery

• Transfusion of red blood cells in the previous 2 months

• Pregnant women

• Contraindications for Mircera according to local prescribing information or as judged by the investigator

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

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical/demographic patient characteristics at initiation of treatment with Mircera		approximately 2 years	No
Primary	Mean time to achieve target Hb range (Hb 10-12 g/dL)		approximately 2 years	No
Primary	Maintenance of Hb levels (patients on ESA with HB 10-12 g/dL): Percentage of patients maintaining Hb level within 1 g/dL of baseline during study period (24 weeks)		approximately 2 years	No
Secondary	Percentage of patients achieving Hb target range (Hb 10-12 g/dL) at least once during study treatment		approximately 2 years	No
Secondary	Maintenance: Mean time spent on Hb level 10-12 g/dL)		approximately 2 years	No
Secondary	Dosage/administration route		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No