A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

Anemia Clinical Trial

Official title:

A Randomized, Open Label Study of the Effect of Intravenous Mircera on the Hemoglobin Response Rate in Patients With Chronic Kidney Disease Who Are on Dialysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546481
• Other study ID #: ML20884
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: September 23, 2010
• Start date: November 2007
• Est. completion date: April 2010

Study information

• Verified date: September 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: KFDA
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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: 81
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia;

• maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion Criteria:

• previous therapy with epoetin within 8 weeks prior to screening;

• overt gastrointestinal bleeding within 8 weeks before screening or during screening period;

• RBC transfusions within 8 weeks before screening or during screening period;

• active malignant disease except non-melanoma skin cancer.

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:
• methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg every 2 weeks
• Epoetin
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

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb response rate (increase in Hb >=1g/dL, and Hb concentration >=11g/dL, without RBC transfusion)		Weeks 0-24	No
Secondary	Hb values, change from baseline, time to Hb response		Throughout study	No
Secondary	Incidence of RBC transfusions		Weeks 0-24	No
Secondary	AEs, laboratory parameters, vital signs, ECGs		Throughout study	No