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

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Roche

Status and phase

Completed
Phase 4

Conditions

Anemia

Treatments

Procedure: Dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01156363
ML22299

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

86 participants in 1 patient group

Single Arm
Experimental group
Treatment:
Procedure: Dialysis
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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