| December 18, 2007 |
| September 22, 2008 |
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| Change in Hb concentration between baseline and efficacy evaluation period (EEP). [ Time Frame: Weeks 13-16 ] [ Designated as safety issue: No ] |
| Change in Hb concentration between baseline and efficacy evaluation period (EEP, weeks 13-16). |
| Complete list of historical versions of study NCT00576602 on ClinicalTrials.gov Archive Site |
- Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- SF36 [ Time Frame: Weeks 16 and 48 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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| Efficacy: Change in Hb conc. over study period; SF36 at wks 16 & 48; % of patients maintaining average Hb conc. within target range; % of patients requiring dose adjustments; incidence of RBC transfusions. Safety: AEs, lab. parameters. |
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| A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant |
| A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant. |
This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
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| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Anemia |
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- Drug: Supportive treatment
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| Terminated |
| 318 |
| February 2010 |
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Inclusion Criteria:
- adult patients, >=18 years of age;
- kidney transplant >=6 months and <5 years prior to randomization;
- anemia;
- no ESA therapy during 3 months prior to randomization.
Exclusion Criteria:
- requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;
- change in Hb concentration >=1.5g/dL during screening period;
- transfusion of red blood cells during 3 months prior to randomization;
- poorly controlled hypertension;
- significant acute or chronic bleeding within 3 months prior to randomization.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, France, Germany, Italy, Spain, United Kingdom |
| |
| NCT00576602 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| MH21299 |
| Hoffmann-La Roche |
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| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
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| Hoffmann-La Roche |
| September 2008 |