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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| ClinicalTrials.gov Identifier: NCT00642304 |
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Recruitment Status :
Completed
First Posted : March 25, 2008
Results First Posted : November 6, 2016
Last Update Posted : June 26, 2018
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anemia | Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.] | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 27, 2008 |
| Actual Primary Completion Date : | December 9, 2009 |
| Actual Study Completion Date : | December 9, 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Anemia
| Arm | Intervention/treatment |
|---|---|
| Experimental: methoxy polyethylene glycol-epoetin beta |
Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
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 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) [ Time Frame: EEP (Weeks 16 to 24) ]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 [ Time Frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) ]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 [ Time Frame: EEP (Weeks 16 to 24) ]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 [ Time Frame: EEP (Weeks 16 to 24) ]The EEP was defined as Week 16 to Week 24.
- Percentage of Participants With Blood Transfusion [ Time Frame: Baseline up to Week 28 ]
- Percentage of Participants With Dose Adjustment [ Time Frame: Baseline up to Week 20 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642304
Locations
Show 23 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00642304 |
| Other Study ID Numbers: |
ML20937 |
| First Posted: | March 25, 2008 Key Record Dates |
| Results First Posted: | November 6, 2016 |
| Last Update Posted: | June 26, 2018 |
| Last Verified: | March 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Anemia Hematologic Diseases Epoetin Alfa Hematinics |