A Study of Mircera for the Treatment of Anemia in Dialysis Patients
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ClinicalTrials.gov Identifier: NCT00077597 |
Recruitment Status :
Completed
First Posted : February 12, 2004
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia | Drug: epoetin Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 182 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
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. |
- Hemoglobin response rate [ Time Frame: Weeks 1-24 ]
- Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00077597

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00077597 |
Other Study ID Numbers: |
BA16736 |
First Posted: | February 12, 2004 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Anemia Hematologic Diseases Epoetin Alfa Hematinics |