A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Anemia Clinical Trial

Official title:

A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00422513
• Other study ID #: ML20336
• Status: Terminated
• Phase: Phase 3
• First received: January 15, 2007
• Last updated: November 9, 2011
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 260
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;

• CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;

• average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

• failed renal transplant within 12 months prior to screening;

• poorly controlled hypertension;

• previous treatment with Mircera.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
• Epoetin alfa
As prescribed, iv, 3 times weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Spent on Anemia Treatment Over Evaluation Period	Efficacy and pharmacoeconomics analyses were not performed.	Months 5-7	No
Primary	Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period	Efficacy and pharmacoeconomics analyses were not performed.	Baseline, Months 5-7	No
Secondary	Number of Participants Assessed for AEs	The adverse events are captured in the adverse event and serious adverse event section of this database.	Month 1 to 15 day follow up post month 7	Yes
Secondary	The Number of Participants With Marked Laboratory Abnormalities Occurring in =5% of the Participants	A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.	Baseline, Month 1 to Month 7	No