A single center study investigating ciclosporine A microemulsion in combination with basiliximab and prednisolon and switch to low-dose ciclosporine A and everolimus without steroids in the prevention of transplant nephropathy in pediatric renal allografts recipients. - Everolimus and Low-Dose Ciclosporine A after induction with Basiliximab, Prednisolone and Ciclospori

Conditions: Kidney transplantation after end stage renal failure
MedDRA version: 9.0Level: LLTClassification code 10014647

Registration Number: EUCTR2006-001407-11-DE

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

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.