|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| A randomized multicenter trial to assess the efficacy of a combined therapy with Sirolimus (Rapamune®), MMF (Cellsept®) and corticosteroids after early elimination of cyclosporin compared to a standard immunosuppression with cyclosporin, MMF and corticosteroids in patients after kidney transplantation |
| ISRCTN | ISRCTN74429508 |
| ClinicalTrials.gov identifier | |
| Public title | A randomized multicenter trial to assess the efficacy of a combined therapy with Sirolimus (Rapamune®), MMF (Cellsept®) and corticosteroids after early elimination of cyclosporin compared to a standard immunosuppression with cyclosporin, MMF and corticosteroids in patients after kidney transplantation |
| Scientific title | |
| Acronym | SMART |
| Serial number at source | 00/03 - A2, V 12.04.2005 |
| Study hypothesis | Early conversion to a calcineurin-inhibitor-free protocol with Sirolimus (Rapamune®) in combination with MMF (Cellcept®) and corticosteroids is superior to a standard protocol with Cyclosporin (Sandimmun®) in combination with MMF (Cellcept®) and corticosteroids at the level of graft-function at 12 months. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Terminal renal failure |
| Participants - inclusion criteria |
1. Male or female patients between 18 and 60 years of age
2. Primary or secondary kidney allograft recipients (PRA <30%) 3. No requirement for dialysis since three days before randomization 4. Women of childbearing potential must have a negative qualitative pregnancy test before Sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for three months following discontinuation of Sirolimus. Any woman becoming pregnant during the treatment period must discontinue Sirolimus treatment 5. Signed and dated informed consent |
| Participants - exclusion criteria |
1. Multiorgan transplant recipients
2. Cold ischemia time >36 hours 3. PRA > 30% 4. Postoperative technical complications necessitating re operation (e.g. kidney artery stenosis) or wound healing disturbances (e.g. voluminous lymphoceles) 5. Recipients of A-B-0 incompatible grafts 6. Body mass index >32 7. Patients with cardiac infarction within six months before study entry or actual unstable coronary heart disease 8. Total number of neutrophile granulocytes <1,500/mm^3 or leucocytes <2,500/mm^3 at screening 9. Patients with severe hepatic impairment (glutamic-oxaloacetic transaminase [GOT], glutamic-pyruvic transaminase [GPT], total bilirubin above three times the norm) 10. Total cholesterol >300 mg/dl and triglycerides >400 mg/dl (even under lipid lowering treatment) 11. Patients with severe intestinal disorders or other diseases significantly influencing resorption, distribution, metabolism and elimination of study medication (except diabetes) at the discretion of the investigator 12. Recipients positive for hepatitis B surface antigens or human immunodeficiency virus (HIV), organs from donors positive for hepatitis B surface antigens or HIV 13. Active malignancies within two years before study entry with the exception of squamous cell carcinoma and basal cell carcinoma of the skin 14. Patients with active systemic infections or significant coagulopathy or requirement of long term anticoagulation therapy after transplantation 15. Use of any investigational drug within four weeks before study entry 16. Known intolerability of Cyclosporine, Sirolimus, MMF or other medication required after transplantation 17. Patients with diseases which potentially could impair study performance at the discretion of the investigator 18. Pregnancy and lactation 19. Refusal to sign informed consent form 20. Patients with ongoing requirement of dialysis at time of randomization |
| Anticipated start date | 01/03/2005 |
| Anticipated end date | 31/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 140 |
| Interventions |
Patients with terminal renal failure undergoing renal transplantation.
After an initial immunosuppression with Cyclosporin, MMF and Steroids for 10-24 days, patients in the study group A are converted to Sirolimus, MMF and Steroids. Patients in the control group continue on Cyclosporin, MMF and Steroids. |
| Primary outcome measure(s) | Graft function at 12 months defined as creatinine clearance calculated according to the Cockroft-Gault formula and serum creatinine level. |
| Secondary outcome measure(s) |
1. Incidence of biopsy proven acute rejection episodes according to Banff 97 classification
2. Patient and graft survival at 12 months 3. Incidence of treatment failure defined as: a. Switch to another immunosuppressive regimen b. Continuing removal of a single immunosuppressant (except MP) c. Switch to another immunosuppressive regimen because of side effects 4. Incidence of infections 5. Incidence of malignancies 6. Incidence of new onset of hypertension 7. Incidence of side effects (e.g. metabolic disorders, others) |
| Sources of funding | Wyeth Pharmaceuticals |
| Trial website | |
| Publications | |
| Contact name | Dr Markus Guba |
| Address |
Dept of Surgery
Hospital of the University of Munich (LMU) Klinikum Grosshadern Marchioninistr. 15 |
| City/town | Munich |
| Zip/Postcode | 81377 |
| Country | Germany |
| Tel | +49 89 7095 3573 |
| Fax | +49 89 7095 6574 |
| markus.guba@med.uni-muenchen.de | |
| Sponsor | University of Munich - Department of Surgery (Germany) |
| Address |
Department of Surgery
Hospital of the University of Munich (LMU) Klinikum Grosshadern Marchioninistrasse 15 |
| City/town | Munich |
| Zip/Postcode | 81377 |
| Country | Germany |
| Tel | +49 89 7095 2790 |
| Fax | +49 89 7095 8893 |
| ml-kks-chirurgie@med.uni-muenchen.de | |
| Sponsor website: | http://www.surgery-grosshadern.de/ |
| Date applied | 20/06/2005 |
| Last edited | 24/10/2007 |
| Date ISRCTN assigned | 04/10/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|