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| autoid | 96 |
| crg_id | CRG010600032 |
| titleoftrial | Observational study on erythropoietin shift from subcutaneous to intravenous administration in hemodialysis patients |
| acronymnoftrial | Italian Study on Erythropoietin Converting (ISEC) |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Pizzarelli |
| leadgivennames | Francesco |
| leadposition | |
| leaddepartment | Nephrology Unit |
| leadorganisation | SM Annunziata Hospital |
| leadaddress | 50011 Antella-Firenze, Italy |
| leademail | fpizzarelli@yahoo.com |
| leadphone | +39 55 249 6223 |
| leadfax | +39 55 249 6520 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | other |
| otherfunding | No funding was provided for this study, but technical support for statistical analysis was provided by Janssen-Cilag SpA, Italy. |
| fundingnameofsponsors | |
| ethicsapproval | no |
| studytype | nonrandomised |
| studytype_other | Single-arm study with historical control |
| groupassignment | |
| blinding_patients | |
| blinding_investigators | |
| blinding_outcomes | |
| blinding_analysts | |
| proposedstart | |
| actualstart | June 2002 |
| proposedcompletiondate | |
| actualcompletiondate | June 2003 |
| multi_center_study | yes |
| numberofcentres | 6 |
| multi_national_study | no |
| countrycentres | Italy |
| researchquestion | To evaluate the effects of changing the route of recombinant human erythropoietin (EPO)administration from subcutaneous to intravenous on mean hemoglobin values and mean EPO dose in stable hemodialysis patients. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | chronic kidney disease, hemodialysis; anemia |
| intervention1 | subcutaneous EPO |
| intervention2 | intravenous EPO |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | at least 18 years |
| totalrecruitment | 265 |
| inclusion | Age > 18 years
Regular hemodialysis (three times per week, same hemodialysis type for at least 6 months) Stable clinical conditions EPO (alpha or beta) treatment (at least 6 months) in maintenance phase Hb >10 g/dl at time of shift from SC to IV EPO administration (T0) Iron status (Ferritin at least 100 ng/ml and TSAT > 20%) |
| exclusion | Patients with clinically significant bleeding or transfusions (last month before the shift from SC to IV)
Chronic inflammation diseases Active malignancies Other haematological disorders |
| primaryoutcomes | Difference in Hb and EPO dose between SC and IV administration. |
| secondaryoutcomes | Measures of iron stores (transferrin saturation and serum ferritin), C-reactive protein, intact parathyroid hormone, and albumin were monitored as control parameters. Variability in Hb and EPO data between centers. |
| reference | 1. Pizzarelli F. David S. Sala P. Icardi A. Casani A. Iron-replete hemodialysis patients do not require higher EPO dosages when converting from subcutaneous to intravenous administration: results of the Italian Study on Erythropoietin Converting (ISEC). American Journal of Kidney Diseases. 47(6):1027-35, 2006 Jun. |