A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

Anemia Clinical Trial

Official title:

An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922610
• Other study ID #: ML21983
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2009
• Last updated: November 1, 2016
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2010
• Est. primary completion date: July 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 (Hb >8 and <11 g/dL);

• regular dialysis or predialysis, not treated with ESA.

Exclusion Criteria:

• transfusion of red blood cells during previous 8 weeks;

• poorly controlled hypertension;

• overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;

• active malignant disease (except melanoma of skin).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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]
sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients		24 weeks after first dose, through week 25	No
Secondary	>=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments		At end of 24 weeks treatment	No