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| autoid | 64 |
| crg_id | CRG110500016 |
| titleoftrial | A Pilot Randomised Controlled Trial Of The Effectiveness And Safety Of Campath As An Induction Agent For Prevention Of Graft Rejection And Preservation Of Renal Function In Patients Receiving Kidney Transplants |
| acronymnoftrial | CampAsia |
| website | http:// |
| identificationno | SQKT01 |
| leadprefix | A/Prof |
| leadsurname | Anantharaman |
| leadgivennames | Vathsala |
| leadposition | Senior Consultant Nephrologist |
| leaddepartment | Department of Renal Medicine |
| leadorganisation | Singapore General Hospital |
| leadaddress | Outram Road, Singapore 169608 |
| leademail | vathsala@nus.edu.sg |
| leadphone | +65 6321 4436 |
| leadfax | +65 6220 2308 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Suresh |
| contactgivennames | Shirley |
| contactposition | Head |
| contactdepartment | Quality Assurance |
| contactorganisation | Clinical Trials and Epidemiology Research Unit |
| contactaddress | 226 Outram Road, Block B, #03-02, Singapore 169039 |
| contactemail | shirley@cteru.com.sg |
| contactphone | +65 63257080 |
| contactfax | +65 63242700 |
| funding | govt|industry |
| otherfunding | |
| fundingnameofsponsors | National Medical Research Council, Ministry of Health, Singapore;ILEX Pharmaceuticals |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | |
| actualstart | 26/10/2001 |
| proposedcompletiondate | |
| actualcompletiondate | 04/09/2006 |
| multi_center_study | yes |
| numberofcentres | 3 |
| multi_national_study | yes |
| countrycentres | Malaysia, Philippines, Singapore |
| researchquestion | To compare, following kidney transplantation, the effectiveness of Alemtuzumab (CAMPATH?) and low dose cyclosporine versus conventional cyclosporine based regimens for the prevention of graft rejection, preservation of renal function and safety .
|
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Renal transplantation |
| intervention1 | Alemtuzumab with low-dose cyclosporine monotherapy |
| intervention2 | Full dose cyclosporine with azathioprine and corticosteroids |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | |
| age | 21-56 years |
| totalrecruitment | 30 |
| inclusion | 1.Aged 18 ? 65 years
2.Renal failure with no previous renal transplantation 3.Kidney transplant recipient 4.Written informed consent |
| exclusion | 1.Pregnant or nursing women or women unwilling/unable to practice an acceptable form of birth control
2.Major systemic or other illness that would, in the opinion of the Investigator, interfere with the patient\'s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results 3.Multi-organ transplant recipients 4.Prior renal transplants 5.Previous treatment with CAMPATH? 6.Use of other investigational agents within 6 weeks 7.Active infection 8.HIV, Hepatitis B surface antigen and/or anti-hepatitis C antibody positive 9.Lymphocyte cytotoxicity cross-match between recipient serum and donor cells positive 10.Autoimmune hemolytic anemia 11.Past history of anaphylaxis following exposure to humanised monoclonal antibodies 12.Panel reactive antibodies (PRA) >85% 13.Patients requiring mycophenolate mofetil as primary immunosuppression 14.Inability to undergo transplant biopsy, including patients who will require anticoagulation 15.Patients in whom graft function or perfusion cannot be demonstrated within 5 hours post-surgery |
| primaryoutcomes | 1.Creatinine levels 6 and 12 months after transplant
2.Incidence of acute cellular rejection (biopsy proven) 3.Graft survival |
| secondaryoutcomes | 1.Creatinine levels at 24 and 36 months after transplant
2.Incidence of steroid resistant/recurrent rejection 3.Incidence of chronic rejection (biopsy preferred) 4.Incidence of delayed graft function 5.Treatment failure from all causes 6.Patient survival 7.Cumulative and actual steroid dose at 6, 12, 24 and 36 months after transplantation 8.Cyclosporine dose in mg/day and mg/kg/day at 6, 12, 24 and 36 months after transplantation 9.Lymphocyte counts 10.Bone density measurements 11.Quality of life ? SF36 12.Cost of treatment (including hospital bed days) |
| reference | 1.Anantharaman Vathsala, Enrique T Ona, Si-Yen Tan , Shirley Suresh, Huei-Xin Lou, Concesca B Cabanayan Casasola, Hung-Chew Wong, David Machin,Gilbert SC Chiang, Romina A Danguilan, and Roy Calne. Randomized Trial Of Alemtuzumab For Prevention Of Graft Rejection And Preservation Of Renal Function After Kidney Transplantation. Transplantation. 2005 Sept 80(6):765-774.
2.Anantharaman Vathsala, Enrique T Ona, Si-Yen Tan , Shirley Suresh, Huei-Xin Lou, Concesca B Cabanayan Casasola, Zhu Ming, David Machin, Roy Calne. One Year Results Of A Pilot Randomised Controlled Trial Of The Effectiveness Of Alemtuzumab As An Induction Agent For Prevention Of Graft Rejection And Preservation Of Renal Function In Patients Receiving Kidney Transplants. Presentation at World Congress of Nephrology. June 2005. 3.Anantharaman Vathsala, Enrique T Ona, Si-Yen Tan, Shirley Suresh, Huei-Xin Lou, Concesca B Cabanayan Casasola, Zhu Ming, David Machin, Roy Calne.Lymphocyte Recovery After Depletion By Alemtuzumab In Renal Transplant Recipients: Impact On Outcome. Presentation at American Transplant Congress, Seattle, USA, May 2005. 4.A Vathsala, Enrique T Ona, Si Yen Tan, Shirley Suresh, Huei-Xin Lou, Concesca B Cabanayan Casasola, Hung-Chew Wong, David Machin, Gilbert SC Chiang, Romina A Danguilan, Roy Calne Safety And Efficacy Of Campath-1H (MABCAMPATH ?) With Low Dose Cyclosporine Monotherapy In Patients Receiving Kidney Transplants ? 6 Month Analysis Of The Pilot Randomised Controlled Trial. Presentation at International Transplant Congress at Vienna, Austria September 2004. 5.Anantharaman Vathsala, Enrique T Ona, Si-Yen Tan, Shirley Suresh, Yiong-Huak Chan, Huei-Xin Lou, Msc, Concesca B Cabanayan Casasola, Jorgen Seldrup, Roy Calne Effectiveness Of Campath-1h (Mabcampath?) As An Induction Agent For Prevention Of Graft Rejection And Preservation Of Renal Function In Patients Receiving Kidney Transplants. Presentation at American Transplant Congress, Boston, USA, May 2004. |