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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00576602 |
Purpose
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.
| Condition | Intervention | Phase |
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: Supportive treatment |
Phase IV |
| MedlinePlus related topics: | Anemia Kidney Transplantation |
| ChemIDplus related topics: | Epoetin alfa Erythropoietin Epoetin beta |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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. |
| Estimated Enrollment: | 318 |
| Estimated Study Completion Date: | February 2010 |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
|
| 2: Active Comparator |
Drug: Supportive treatment
As prescribed
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: PDO_MH21299 | 973-235-5000 | |
| Contact: or | 800-526-6367 (FOR US ONLY) |
| Belgium | |||||
| Recruiting | |||||
| LEUVEN, Belgium, 3000 | |||||
| Recruiting | |||||
| GENT, Belgium, 9000 | |||||
| Recruiting | |||||
| EDEGEM, Belgium, 2650 | |||||
| France | |||||
| Recruiting | |||||
| TOULOUSE, France, 31054 | |||||
| Recruiting | |||||
| PARIS, France, 75475 | |||||
| Recruiting | |||||
| AMIENS, France, 80054 | |||||
| Recruiting | |||||
| TOURS, France, 37044 | |||||
| Recruiting | |||||
| NICE, France, 06002 | |||||
| Recruiting | |||||
| LE KREMLIN-BICETRE, France, 94275 | |||||
| Recruiting | |||||
| CAEN, France, 14033 | |||||
| Germany | |||||
| Recruiting | |||||
| BERLIN, Germany, 13353 | |||||
| Recruiting | |||||
| KAISERSLAUTERN, Germany, 67655 | |||||
| Recruiting | |||||
| KIEL, Germany, 24105 | |||||
| Recruiting | |||||
| MÜNCHEN, Germany, 80336 | |||||
| Not yet recruiting | |||||
| BONN, Germany, 53127 | |||||
| Italy | |||||
| Recruiting | |||||
| BARI, Italy, 70124 | |||||
| Poland | |||||
| Not yet recruiting | |||||
| GDANSK, Poland, 80-211 | |||||
| Not yet recruiting | |||||
| SZCZECIN, Poland, 70-111 | |||||
| Not yet recruiting | |||||
| WROCLAW, Poland, 50-417 | |||||
| Not yet recruiting | |||||
| WARSZAWA, Poland, 02-006 | |||||
| Not yet recruiting | |||||
| POZNAN, Poland, 60-479 | |||||
| Spain | |||||
| Recruiting | |||||
| BARCELONA, Spain, 08036 | |||||
| Recruiting | |||||
| SEVILLA, Spain, 41013 | |||||
| United Kingdom | |||||
| Recruiting | |||||
| LONDON, United Kingdom, SE22 8PT | |||||
| Not yet recruiting | |||||
| NOTTINGHAM, United Kingdom, NG5 1PB | |||||
| Hoffmann-La Roche |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | MH21299 |
| First Received: | December 18, 2007 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00576602 |
| Health Authority: | France:Agence francaise de Securite Sanitaria des Products de Sante (AFSSAPS) |
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