A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.

Anemia Clinical Trial

Official title:

An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of Mircera in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559273
• Other study ID #: NH20052
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2007
• Last updated: May 5, 2014
• Start date: December 2007
• Est. completion date: June 2010

Study information

• Verified date: May 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: WIRB
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease;

• anemia;

• not on dialysis.

Exclusion Criteria:

• previous therapy with any ESA within 12 weeks prior to screening;

• renal allograft in place;

• immunosuppressive therapy in the 12 weeks prior to screening.

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 [Mircera]
1.2 micrograms/kg sc monthly, starting dose
• Darbepoetin alfa
0.45 micrograms/kg sc weekly, starting dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb response rate, and change in average Hb concentration		Weeks 0-28	No
Secondary	Hb values and change over time; time to target Hb response; incidence of RBC transfusions; percentage of patients with stable Hb response; number of dose adjustments required		Throughout study	No
Secondary	Percentage of patients with >=1 Hb >12g/dL		Weeks 0-8	No
Secondary	AEs, laboratory parameters, vital signs		Throughout study	No