Clinical trial NCT00517881: Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis 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: TERMINATED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 29
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, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.


Eligibility criteria: Inclusion Criteria:

* Chronic renal anemia
* Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
* Adequate iron status (serum ferritin greater than \[\>\] 100 nanogram per milliliter and Transferrin Saturation \>20 percent \[%\] or hypochromic red cells less than \[\<\] 10%)
* Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
* Acute or chronic bleeding
* Active malignant disease (except non-melanoma skin cancer)

Primary outcomes:
measure: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
timeFrame: Week 17 up to Week 24
Secondary outcomes:
measure: Change in Hemoglobin Concentration Between Reference (SVP) and EEP
timeFrame: Week 17 up to Week 24
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
timeFrame: Week 17 up to Week 24
measure: Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
timeFrame: Week 17 up to Week 24
measure: Percentage of Participants Requiring Any Dose Adjustment
timeFrame: Week 1 up to Week 16 and Week 17 up to Week 24
measure: Percentage of Participants With Red Blood Cell Transfusion During the Study
timeFrame: Week 0 up to Week 24
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Week 0 up to Week 24
Other outcomes:
Locations:
city: Danderyd
country: Sweden
city: Eksjo
country: Sweden
city: Eskilstuna
country: Sweden
city: Gaevle
country: Sweden
city: Goeteborg
country: Sweden
city: Gothenburg
country: Sweden
city: Huddinge
country: Sweden
city: Jonkoping
country: Sweden
city: Kristianstad
country: Sweden
city: Skellefteå
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Värnamo
country: Sweden
city: Västervik
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: