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

Phase 4

Completed

• Conditions: Anemia
• Interventions: Procedure: Dialysis; Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT01156363
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Study Start: 2010-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-10
• Results First Submitted: 2015-10-30
• Results First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Results First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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Exclusion Criteria

• uncontrolled hypertension
• haemoglobinopathy
• anaemia due to haemolysis
• pure red cell aplasia (PRCA)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Dialysis	-
Single Arm	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range	Weeks 1 to 32	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.

Secondary Outcome Measures

Name	Time	Method
Mean Monthly Hb Values	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8	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).
Change in Hb Concentration Between Reference and Treatment Period	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8	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).
Mean Time Participants Spent Having Hb Concentration Within Target Range	Weeks 1 to 32	Target Hb concentration was between 10.0 and 12.0 g/dL.
Percentage of Participants Requiring Dose Adjustments	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	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.