Phase 4
N=86
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01156363 ↗Enrolled (actual)
86
Serious AEs
16.3%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range — 77.1; 88.5; 90.9; 84.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dialysis (Procedure); methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range |
77.1; 88.5; 90.9; 84.3 | — |
| SECONDARY Mean Monthly Hb Values |
10.7; 11.1; 10.8; 10.8; 10.7; 11.3 | — |
| SECONDARY Change in Hb Concentration Between Reference and Treatment Period |
-0.0; 0.1; 0.1; 0.1; 0.1; -0.3 | 0.9825 |
| SECONDARY Mean Time Participants Spent Having Hb Concentration Within Target Range |
112.6; 105.0; 107.6; 108.9 | — |
| SECONDARY Percentage of Participants Requiring Dose Adjustments |
7.4; 61.7; 21.0; 9.9; 4.0; 69.3 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01156363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.