An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01690455
First received: September 19, 2012
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.
| Condition |
|---|
|
Anemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Proportion of patients who achieve a hemoglobin level of >/=10 g/dl [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 246 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with renal anemia and on dialysis therapy
Criteria
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Adequate iron status
- Signed informed consent form
Exclusion Criteria:
- Anemia due to non-renal causes
- Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
- Pregnant or lactating female patients
- Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690455
Contacts
| Contact: Please reference Study ID Number: ML25701 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Poland | |
| Recruiting | |
| Bartoszyce, Poland, 11-200 | |
| Recruiting | |
| Bydgoszcz, Poland, 85-681 | |
| Recruiting | |
| Ciechanow, Poland, 06-400 | |
| Recruiting | |
| Czestochowa, Poland, 42-200 | |
| Recruiting | |
| Debica, Poland, 39-200 | |
| Recruiting | |
| Gliwice, Poland, 44-100 | |
| Recruiting | |
| Gorzow Wielkopolski, Poland, 64-400 | |
| Recruiting | |
| Grudziadz, Poland, 86-300 | |
| Recruiting | |
| Hajnowka, Poland, 17-200 | |
| Recruiting | |
| Kepno, Poland, 63-600 | |
| Recruiting | |
| Konin, Poland, 62-504 | |
| Completed | |
| Koscierzyna, Poland, 83-400 | |
| Recruiting | |
| Lodz, Poland, 90-153 | |
| Recruiting | |
| Milicz, Poland, 56-300 | |
| Recruiting | |
| Pila, Poland, 64-920 | |
| Recruiting | |
| Polanica Zdroj, Poland, 57-320 | |
| Recruiting | |
| Radom, Poland, 26-610 | |
| Recruiting | |
| Rybnik, Poland, 44-200 | |
| Recruiting | |
| Rzeszow, Poland, 35-301 | |
| Recruiting | |
| Rzeszow, Poland, 35-055 | |
| Recruiting | |
| Sandomierz, Poland, 27-600 | |
| Recruiting | |
| Siedlce, Poland, 08-110 | |
| Recruiting | |
| Slupsk, Poland, 76-200 | |
| Recruiting | |
| Starachowice, Poland, 27-200 | |
| Recruiting | |
| Suwalki, Poland, 16-400 | |
| Recruiting | |
| Warszawa, Poland, 04-141 | |
| Recruiting | |
| Wolomin, Poland, 05-200 | |
| Recruiting | |
| Wroclaw, Poland, 51-124 | |
| Recruiting | |
| Zgorzelec, Poland, 59-900 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01690455 History of Changes |
| Other Study ID Numbers: | ML25701 |
| Study First Received: | September 19, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Poland: Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013