Clinical trial NCT00642304: A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Official title: A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 20
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 efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.


Eligibility criteria: Inclusion Criteria:

* Chronic renal anemia
* Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

* Transfusion of red blood cells during previous 8 weeks
* Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
* Acute or chronic bleeding requiring therapy within previous 8 weeks

Primary outcomes:
measure: Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
timeFrame: EEP (Weeks 16 to 24)
Secondary outcomes:
measure: Mean Change in Hb Concentration Between SVP and the EEP
timeFrame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
measure: Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
timeFrame: EEP (Weeks 16 to 24)
measure: Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
timeFrame: EEP (Weeks 16 to 24)
measure: Percentage of Participants With Blood Transfusion
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Dose Adjustment
timeFrame: Baseline up to Week 20
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Twenteborg Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
city: Amsterdam
country: Netherlands
facility: Bovenij Zkhs; Cardiologie Afd.
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis; Inwendige Geneeskunde
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis; Inwendige Geneeskunde
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier De Graaf Groep
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis; Inwendige Geneeskunde
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
city: Drachten
country: Netherlands
facility: Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
city: Goes
country: Netherlands
facility: Oosterscheldeziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum; Nephrology
city: Hoogeveen
country: Netherlands
facility: Bethesda Hospital; Internal Medicine
city: Leiden
country: Netherlands
facility: Leiden University Medical Center; Nierziekten
city: Leiderdorp
country: Netherlands
facility: Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
city: Maastricht
country: Netherlands
facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
city: Nijmegen
country: Netherlands
facility: Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
city: Rotterdam
country: Netherlands
facility: Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
city: Rotterdam
country: Netherlands
facility: Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis; Interne Oncologie
city: Terneuzen
country: Netherlands
facility: Zorgsaam Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: