Kidney transplantation after end stage renal failure MedDRA version: 9.0 Level: LLT Classification code 10014647
Conditions
Interventions
Product Name: Certican
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Other descriptive name: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are males or non-pregnant females between the ages of 1 and 18 years. 2. Patients who are recipients of primary or secondary renal allografts. 3. Patients who are single-organ recipients (kidney only). 4. Women of childbearing potential must have a negative serum pregnancy test before study start. 5. Women of childbearing potential must use two reliable forms of contraception simultaneously unless abstinence is the chosen method. Effective contraception must be used before study start, during study, and for 6 weeks following discontinuation of study. 6. Patients who are able to receive oral medication. 7. Patients (resp. their guardians) must be capable of understanding the purpose and risks of the study. 8. Patients (resp. their guardians) who are willing to give written informed consent and willing to participate in and comply with the study protocol. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients whose donor kidney cold ischemia time (CIT) is longer than 36 hours. 2. Patients who have previously undergone an organ transplant other than one renal transplant. 3. Patients with a peak or current PRA of >50%. 4. Patients previously treated with basiliximab. 5. Patients who have received an immunosuppressive investigational drug 6 months prior to transplantation. 6. Pregnant and/or lactating women and women of childbearing potential who are unwilling or unable to use contraception methods as specified. 7. Patients with severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication and patients with severe diarrhea, with a white blood count of less than 2.5 ? 109/L (IU), platelet count of less than 100 ? 109/L (IU), or hemoglobin less than 60 G/L, at the time of entry into the study, with active peptic ulcer disease or receiving bile-acid sequestrants. 8. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. 9. Patients with known positive HIV-1 or HCV test or the presence of HBsAg. 10. Patients with malignancies or history of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate graft function under an immunosuppressive regimen consisting of everolimus/CsA after induction with basiliximab/CsA/prednisolone during the first 12 months post-transplantation in pediatric de novo renal allografts recipients. ;Secondary Objective: a) Time to first biopsy proven acute rejection episode b) The presence of biopsy confirmed Grade I, II, or III chronic allograft nephropathy 6 months after transplantation c) Growth after steroid reduction d) Change of blood pressure after switch to everolimus / low dose CsA e) Incidence of infections (i.e. CMV) f) Number of CMV-specific-T-cells and adenovirus-specific T-cells under the changing immunosuppressive regimens in correlation to CMV- and Adenovirus-infections g) Number of dialyses after transplantation ;Primary end point(s): Graft function under an immunosuppressive regimen consisting of everolimus/CsA after induction with basiliximab/CsA/prednisolone 12 months post-transplantation in pediatric de novo renal allografts recipients. | — |
Countries
Germany
Outcome results
None listed