An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

Anemia Clinical Trial

Official title:

IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974271
• Other study ID #: ML28980
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: November 1, 2016
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission national de l'informatique et des libertés (CNIL)
• Study type: Observational

Clinical Trial Summary

This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• 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

• Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months

• Previously treated with an erythropoietin stimulating agent (ESA)

• Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons

• Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL

Exclusion Criteria:

• Current participation in a clinical trial on renal anemia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6		6 months	No
Secondary	Percentage of patients with Hb value within the range of 10 - 12 g/dL		6 months	No
Secondary	Change in Hb level		from baseline to Month 6	No
Secondary	Monthly dose of Mircera		6 months	No
Secondary	Safety: Incidence of adverse events		6 months	No