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

Hoffmann-La Roche86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

DialysisPROCEDURE

regular haemodialysis or peritoneal dialysis

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

once monthly, subcutaneously or intravenously, for 32 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Unnamed facility

Kaohsiung City, Taiwan

Unnamed facility

New Taiepei City, Taiwan

Unnamed facility

Taichung, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: Weeks 1 to 32

Secondary Outcomes

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).

Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

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).

Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8

Mean Time Participants Spent Having Hb Concentration Within Target Range

Target Hb concentration was between 10.0 and 12.0 g/dL.

Time frame: Weeks 1 to 32

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.

Time frame: 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

Data from ClinicalTrials.gov

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