Clinical trial NCT00773968: A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-Dialysis Patients With Chronic Renal Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).


Eligibility criteria: Inclusion Criteria:

* Chronic renal anemia;
* Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
* Hb concentration between 10 and 12 g/dL;
* Adequate iron status.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
* Active malignant disease.

Primary outcomes:
measure: Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)
timeFrame: EEP: Weeks 17 to 28
Secondary outcomes:
measure: Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)
timeFrame: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28
measure: Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP
timeFrame: EEP: Weeks 17 to 28
measure: Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP
timeFrame: EEP: Weeks 17 to 28
measure: Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
timeFrame: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28
measure: Percentage of Participants Who Required Red Blood Cell Transfusions
timeFrame: Weeks 1 to 28
Other outcomes:
Locations:
city: Caserta
country: Italy
state: Campania
city: Eboli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Nola
country: Italy
state: Campania
city: Solofra
country: Italy
state: Campania
city: Tivoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Albano Laziale
country: Italy
state: Lazio
city: Civita Castellana
country: Italy
state: Lazio
city: Viterbo
country: Italy
state: Lazio
city: Savona
country: Italy
state: Liguria
city: Cinisello Balsamo
country: Italy
state: Lombardia
city: Cremona
country: Italy
state: Lombardia
city: Mantova
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: S Fermo Della Battaglia
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Pesaro
country: Italy
state: Marche
city: Campobasso
country: Italy
state: Molise
city: Alessandria
country: Italy
state: Piemonte
city: Chivasso
country: Italy
state: Piemonte
city: Barletta
country: Italy
state: Puglia
city: Molfetta (Ba)
country: Italy
state: Puglia
city: Putignano
country: Italy
state: Puglia
city: Catania
country: Italy
state: Sicilia
city: Erice
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Pistoia
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: