A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
This study has been withdrawn prior to enrollment.
(The study was cancelled before any patients were enrolled, due to operational reasons.)
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560547
First received: November 16, 2007
Last updated: February 15, 2008
Last verified: February 2008
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Purpose
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients maintaining average Hb concentration within target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
- Dose adjustments; RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Other Name: Mircera
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
- continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- active malignant disease (except non-melanoma skin cancer).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00560547 History of Changes |
| Other Study ID Numbers: | ML21349 |
| Study First Received: | November 16, 2007 |
| Last Updated: | February 15, 2008 |
| Health Authority: | Denmark: Laegemiddelstyrelsen (DMA) |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013