A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517881
First received: August 16, 2007
Last updated: November 19, 2010
Last verified: November 2010
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Purpose
This single arm study will assess the efficacy and safety of subcutaneous Mircera for maintenance of hemoglobin levels in pre-dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of Mircera with the starting dose (120, 200 or 360 micrograms) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start. 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 [Mircera] |
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 Subcutaneous Mircera in Pre-dialysis 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 in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Hb concentration and percentage of patients maintaining Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
- Mean time spent in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc monthly, starting dose
|
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;
- continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months;
- acute or chronic bleeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517881
Locations
| Sweden | |
| Bollnas, Sweden, 821 81 | |
| Danderyd, Sweden, 18288 | |
| Eksjo, Sweden, 57581 | |
| Eskilstuna, Sweden, 63188 | |
| Gaevle, Sweden, 80187 | |
| Goeteborg, Sweden, 41345 | |
| Gothenburg, Sweden, S-402 76 | |
| Huddinge, Sweden, 14186 | |
| Jonkoping, Sweden, 55185 | |
| Karlshamn, Sweden, S-374 80 | |
| Karlstad, Sweden, 65185 | |
| Kristianstad, Sweden, 29185 | |
| Linkoeping, Sweden, S-581 85 | |
| Lund, Sweden, 22185 | |
| Skellefteå, Sweden, S-931 86 | |
| Stockholm, Sweden, 17176 | |
| Trollhaettan, Sweden, 46185 | |
| Umea, Sweden, 90185 | |
| Uppsala, Sweden, 75185 | |
| Värnamo, Sweden, 33185 | |
| Västervik, Sweden, 59381 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00517881 History of Changes |
| Other Study ID Numbers: | ML20944 |
| Study First Received: | August 16, 2007 |
| Last Updated: | November 19, 2010 |
| Health Authority: | Sweden: Lakemedelsverket (MPA) |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013