Recipients of a renal allograft from a non-heart-beating donor, three months after transplantation. MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Trade Name: Rapamune
Product Name: Sirolimus
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123889
Concentration unit: mg milligram(s)
Concentration type: range
Concen
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Acceptable renal function (eGFR Nankivell > 30ml, Proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Banff grade > 2 acute or vascular rejection at any time during this transplant pre-randomization 2. Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).. 3. Evidence of active systemic or localized major infection. 4. Use of any investigational drug or treatment up to 4 weeks prior to transplantation. 5. Planned use of agents with a known interaction with any of the following: sirolimus or its derivatives, macrolide antibiotics, corticosteroids, tacrolimus, or IMPDH inhibitor. 6. Immunosuppressive therapies other than those described above 7. Planned treatment with voriconazole, cisapride, or ketoconazole, that will not be discontinued prior to randomization. 8. Treatment with aminoglycosides, amphotericin B, cisplatin, or other drugs associated with renal dysfunction that is not discontinued prior to enrolment. 9. Subjects with a screening/baseline total white blood cell count 400 mg/dL (> 4.5 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy. 11. Subjects who are known to be HIV positive and/or subjects with active Hepatitis B or active Hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of a programmed introduction of a Sirolimus-based, Calcineurin inhibitor free, maintenance immunosuppressive regime, three months after renal transplantation in recipients of a non-heart-beating donor kidney graft on: graft function as determined by eGFR and biopsy proven acute rejection rates at twelve months post randomization to programmed Sirolimus introduction ;Secondary Objective: Graft and patient survival. Infection rate. Malignancy rate. Dyslipidaemia. Proteinuria rate. Change in selectivity index of proteinuria. Blood pressure. Number of antihypertensive drugs. Cardiovascular event rate.;Primary end point(s): eGFR as determined by Nankivell at month 12 post randomization | — |
Countries
Netherlands
Outcome results
None listed