A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

Anemia Clinical Trial

Official title:

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156363
• Other study ID #: ML22299
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: October 30, 2015
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=18 years of age

• chronic renal anaemia

• haemoglobin 10.0-12.0g/dl at screening

• adequate iron status

• continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months

• regular haemodialysis or regular peritoneal dialysis for >/= 3 months

Exclusion Criteria:

• uncontrolled hypertension

• haemoglobinopathy

• anaemia due to haemolysis

• pure red cell aplasia (PRCA)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Procedure:
• Dialysis
regular haemodialysis or peritoneal dialysis

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range	Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.	Weeks 1 to 32	No
Secondary	Mean Monthly Hb Values	The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8	No
Secondary	Change in Hb Concentration Between Reference and Treatment Period	The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8	No
Secondary	Mean Time Participants Spent Having Hb Concentration Within Target Range	Target Hb concentration was between 10.0 and 12.0 g/dL.	Weeks 1 to 32	No
Secondary	Percentage of Participants Requiring Dose Adjustments	Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.	Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8	No