FRESH-PEF74134-en
Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A
MIRIADE
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Nephrology | health theme |
| Chronic kidney disease | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"Inclusion criteria: - Patient aged 18 years or older; - CKD patient on hemodialysis or hemodiafiltration for at least 3 months; - Patient previously treated with an ESA; - Patient for whom the investigator decided to initiate a treatment with Mircera® for medical reasons; - Patient with last hemoglobin level within the range [10 12] g/dL before Mircera® initiation; - Patient having received oral and written information about the study, without any objections for the use of his/her personal data, and having signed a written informed consent form. ","clusion_E":"Patients participating in a clinical trial on renal anemia at inclusion were excluded from study entry."}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2014-01-01 | 2015-01-01 |
| Standard |
|---|
| ['CDISC'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | dir8@impact-dev.tn |
FRESH-PEF74134-en
| Name | Affiliation |
|---|---|
| Camille BACHOT | F. HOFFMANN-LA ROCHE AG |