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| autoid | 123 |
| crg_id | CRG030600052 |
| titleoftrial | ANTI-INTERLEUKIN-2 RECEPTOR MONOCLONAL ANTIBODIES COMBINED WITH TRIPLE IMMUNOSUPPRESSION IN RECIPIENTS OF DECEASED DONOR RENAL ALLOGRAFT |
| acronymnoftrial | ANTI-INTERLEUKIN-2 RECEPTOR MONOCLONAL ANTIBODIES IN RENAL TRANSPLANTATION |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Kandus |
| leadgivennames | Aljosa |
| leadposition | Head |
| leaddepartment | Renal Transplant Center |
| leadorganisation | Department of Nephrology, University Medical Center Ljubljana |
| leadaddress | Zaloska 7, 1525 Ljubljana, Slovenia |
| leademail | aljosa.kandus@guest.arnes.si |
| leadphone | +386 1 522 31 21 |
| leadfax | +386 1 522 22 25 |
| leadsuffix | |
| contactprefix | Ms |
| contactsurname | Grego |
| contactgivennames | Katarina |
| contactposition | |
| contactdepartment | Renal Transplant Center |
| contactorganisation | Department of Nephrology, University Medical Center Ljubljana |
| contactaddress | Zaloska 7, 1525 Ljubljana, Slovenia |
| contactemail | katarina.grego@gmail.com |
| contactphone | +386 1 522 31 21 |
| contactfax | +386 1 522 22 25 |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | |
| actualstart | 01/06/2002 |
| proposedcompletiondate | 01/06/2007 |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Slovenia |
| researchquestion | In prospective, randomized open-label study we investigate safety and efficacy of basiliximab or daclizumab combined with cyclosporine microemulsion, mycophenolate mofetil and methylprednisolone in adult recipients of at least 1-HLA mismatched deceased donor renal allograft.
|
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | renal transplant recipients |
| intervention1 | basiliximab |
| intervention2 | daclizumab |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | Minimum 18 yrs |
| totalrecruitment | 200 |
| inclusion | Adult end-stage renal disease patients with at least 1-HLA mismatched deceased donor renal allograft. |
| exclusion | Non-adherence to predicted immunosuppression protocol. |
| primaryoutcomes | Incidence of acute renal allograft rejection. |
| secondaryoutcomes | Patient survival.
Graft survival. Graft function. Immunosuppression unwanted effects. |
| reference | Kandus A, Arnol M, Omahen K, Oblak M, Vidan-Jeras B, Kmetec A, Bren AF Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study Transplantation 2010 89(8):1022-1027 Grego K, Arnol M, Bren AF, Kmetec A, Tomazic J, Kandus A Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal graft recipients Transplantation Proceedings 2007; 39(10):3093-97 Grego K, Kandus A, Bren AF Basiliximab versus daclizumab for prevention of acute renal allograft rejection [abstract no: TH-PO544] Journal of the American Society of Nephrology 2006; 17 Abstracts: 223A |