Trial information
CARISMA Study: A Study of Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Status: Recruiting
Protocol number: ML21438
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for the maintenance of haemoglobin levels in hemodialysis patients with chronic renal anaemia
Brief summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10-12g/dL. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 400.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) Time frame: Weeks 17-24
Key secondary outcomes: 1. Change in Hb concentration Time frame: Between reference and EEP
2. Proportion of patients maintaining Hb concentration within the target range Time frame: Weeks 17-24
3. Median time spent in Hb target range Time frame: Throughout study
4. Proportion of patients requiring dose adjustments; incidence of RBC transfusions Time frame: Weeks 0-24
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- continuous iv maintenance ESA treatment during previous month;
- regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- active malignant disease (except non-melanoma skin cancer).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Acireale
- Agrigento
- Ancona
- Anzio
- Arenzano
- Ascoli Piceno
- Avellino
- Avezzano
- Bari
- Benevento
- Bollate
- Bolzano
- Borgomanero
- Brescia
- Brindisi
- Cagliari
- Casorate Primo (Pv)
- Cassino
- Castellammare
- Catania
- Cernusco Sul Naviglio
- Chieri
- Chieti
- Civitavecchia
- Cosenza
- Desio
- Ferrara
- Firenze
- Foggia
- Genova
- La Spezia
- Lecco
- Legnano
- Lodi
- Lucera
- Mantova
- Marsciano
- Matera
- Milano
- Milazzo
- Montevarchi
- Napoli
- Nocera Inferiore
- Novara
- Nuoro
- Ostia Lido
- Palermo
- Pavia
- Perugia
- Piacenza
- Pisa
- Pontedera
- Ravenna
- Reggio Emilia
- Roma
- San Daniele Del Friuli
- San Miniato
- Sassari
- Sciacca
- Senigallia
- Taranto
- Teramo
- Torino
- Udine
- Vasto (Ch)
- Verona
- Vicenza
- Vizzolo Predabissi
