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 transplantatio
- Conditions
- Terminal renal failureSurgery
- Registration Number
- ISRCTN74429508
- Lead Sponsor
- niversity of Munich - Department of Surgery (Germany)
- Brief Summary
2010 results in https://pubmed.ncbi.nlm.nih.gov/20463641/ (added 07/07/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 140
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft function at 12 months defined as creatinine clearance calculated according to the Cockroft-Gault formula and serum creatinine level.
- Secondary Outcome Measures
Name Time Method <br> 1. Incidence of biopsy proven acute rejection episodes according to Banff 97 classification<br> 2. Patient and graft survival at 12 months<br> 3. Incidence of treatment failure defined as:<br> a. Switch to another immunosuppressive regimen<br> b. Continuing removal of a single immunosuppressant (except MP)<br> c. Switch to another immunosuppressive regimen because of side effects<br> 4. Incidence of infections<br> 5. Incidence of malignancies<br> 6. Incidence of new onset of hypertension<br> 7. Incidence of side effects (e.g. metabolic disorders, others)<br>