A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

Anemia Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of Maintenance Subcutaneous Mircera on Hemoglobin Levels in Dialysis Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077623
• Other study ID #: BA16740
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2004
• Last updated: October 1, 2015
• Start date: March 2004
• Est. completion date: March 2006

Study information

• Verified date: October 2015
• 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 (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. 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: 572
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• on dialysis therapy for at least 12 weeks before screening;

• receiving sc epoetin for at least 8 weeks before screening.

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

Intervention

Drug:
• epoetin alfa or beta
iv 3 times weekly, as prescribed
• methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 2 weeks
• methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Mexico,  New Zealand,  Panama,  Poland,  Puerto Rico,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration		Weeks 1-36	No
Secondary	Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration\n		Weeks 29-36	No
Secondary	RBC transfusions		Weeks 1-36	No
Secondary	AEs, laboratory parameters, vital signs		Throughout study	No