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A Study of Mircera for the Treatment of Anemia in Dialysis Patients
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077597
First received: February 10, 2004
Last updated: November 1, 2016
Last verified: November 2016
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Purpose
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
| Anemia | Drug: epoetin Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Hemoglobin response rate [ Time Frame: Weeks 1-24 ]
Secondary Outcome Measures:
- Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n [ Time Frame: Throughout study ]
| Enrollment: | 182 |
| Study Start Date: | February 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv (starting dose) once every 2 weeks
|
| Active Comparator: 2 |
Drug: epoetin
3 times a week iv, as prescribed.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- dialysis therapy for at least 2 weeks before screening.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 4 weeks before screening.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00077597
Show 59 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077597
Show 59 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00077597 History of Changes |
| Other Study ID Numbers: |
BA16736 |
| Study First Received: | February 10, 2004 |
| Last Updated: | November 1, 2016 |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases Epoetin Alfa Hematinics |
ClinicalTrials.gov processed this record on June 23, 2017