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

Anemia Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081471
• Other study ID #: BA16738
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2004
• Last updated: November 1, 2016
• Start date: June 2004
• Est. completion date: July 2006

Study information

• Verified date: November 2016
• 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 study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• 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 therapy;

• not receiving epoetin.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• administration of another investigational drug within 4 weeks before screening, or during the study period.

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:
• darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly
• methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Greece,  Italy,  Netherlands,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin response rate		Weeks 1-28	No
Secondary	Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n		Throughout study	No