Back to resultsA Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
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
Sites / Locations
- Twenteborg Ziekenhuis
- Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
- Bovenij Zkhs; Cardiologie Afd.
- Wilhelmina Ziekenhuis; Inwendige Geneeskunde
- Rode Kruis Ziekenhuis; Inwendige Geneeskunde
- Amphia Ziekenhuis
- Reinier De Graaf Groep
- Slingeland Ziekenhuis; Inwendige Geneeskunde
- Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
- Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
- Oosterscheldeziekenhuis
- Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
- Atrium Medisch Centrum; Nephrology
- Bethesda Hospital; Internal Medicine
- Leiden University Medical Center; Nierziekten
- Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
- Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
- Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
- Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
- Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
- Ikazia Ziekenhuis; Interne Oncologie
- Zorgsaam Ziekenhuis
- Diakonessenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
methoxy polyethylene glycol-epoetin beta
Arm Description
Outcomes
Primary Outcome Measures
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)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Secondary Outcome Measures
Mean Change in Hb Concentration Between SVP and the EEP
The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Percentage of Participants With Blood Transfusion
Percentage of Participants With Dose Adjustment
A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642304
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 27, 2008 (Actual)
Primary Completion Date
December 9, 2009 (Actual)
Study Completion Date
December 9, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
methoxy polyethylene glycol-epoetin beta
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Intervention Description
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
Primary Outcome Measure Information:
Title
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)
Description
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Time Frame
EEP (Weeks 16 to 24)
Secondary Outcome Measure Information:
Title
Mean Change in Hb Concentration Between SVP and the EEP
Description
The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Time Frame
SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Title
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
Description
The EEP was defined as Week 16 to Week 24.
Time Frame
EEP (Weeks 16 to 24)
Title
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
Description
The EEP was defined as Week 16 to Week 24.
Time Frame
EEP (Weeks 16 to 24)
Title
Percentage of Participants With Blood Transfusion
Time Frame
Baseline up to Week 28
Title
Percentage of Participants With Dose Adjustment
Description
A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Time Frame
Baseline up to Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Twenteborg Ziekenhuis
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
Bovenij Zkhs; Cardiologie Afd.
City
Amsterdam
ZIP/Postal Code
1034 CS
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis; Inwendige Geneeskunde
City
Assen
ZIP/Postal Code
9401 RK
Country
Netherlands
Facility Name
Rode Kruis Ziekenhuis; Inwendige Geneeskunde
City
Beverwijk
ZIP/Postal Code
1942LE
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Reinier De Graaf Groep
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Slingeland Ziekenhuis; Inwendige Geneeskunde
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
City
Drachten
ZIP/Postal Code
9202 NN
Country
Netherlands
Facility Name
Oosterscheldeziekenhuis
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Atrium Medisch Centrum; Nephrology
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Bethesda Hospital; Internal Medicine
City
Hoogeveen
ZIP/Postal Code
7909
Country
Netherlands
Facility Name
Leiden University Medical Center; Nierziekten
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
City
Leiderdorp
ZIP/Postal Code
2353 GA
Country
Netherlands
Facility Name
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
City
Rotterdam
ZIP/Postal Code
3078 HT
Country
Netherlands
Facility Name
Ikazia Ziekenhuis; Interne Oncologie
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Zorgsaam Ziekenhuis
City
Terneuzen
ZIP/Postal Code
4535 PA
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
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