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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • Cavite, Philippines, 4103
  • Makati City, Philippines, 1229
  • Manila, Philippines, 1000
  • Marikina, Philippines, 1805
  • Pasig City, Philippines, 1605

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
>=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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21983