An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)

Anemia Clinical Trial

Official title:

Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213485
• Other study ID #: ML22643
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: November 1, 2016
• Start date: March 2010
• Est. completion date: October 2011

Study information

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

Clinical Trial Summary

This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Chronic kidney disease, on dialysis for > 3 months

• Treatment-naïve or previous treatment with ESA

• Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion Criteria:

• Participation in a clinical trial

• Anemia due to an associated malignant pathology

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

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	Haemoglobin levels		Month 6	No
Primary	Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice		Month 6	No
Secondary	Change in haemoglobin/haematocrit		from baseline to Month 12	No
Secondary	Biological parameters of anemia: transferrin saturation, serum ferritin, folates		12 months	No
Secondary	Efficacy of dialysis (Kt/V, urea levels)		12 months	No
Secondary	Safety: Incidence of adverse events		12 months	No
Secondary	Compliance (treatment modification or discontinuation)		12 months	No
Secondary	Quality of life: Short Form (SF-36) questionnaire		12 months	No