EUCTR2010-024381-21-GB进行中（未招募）1 期
A 12-month, multicenter, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up - not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion criteria at baseline (transplantation)
- •1-Written informed consent/assent must be obtained from the parent(s) or legal guardian before any assessment is performed.
- •2- Primary or secondary paediatric kidney transplant recipient aged greater than or equal to 1 year and younger than 18 years receiving a deceased donor or non-HLA identical living donor (related or unrelated) renal transplant.
- •Inclusion criteria at randomization (4-6 weeks after transplantation)
- •1-Patients on TAC + MMF + steroids.
- •2- Renal function with eGFR > 40 ml/min/1.73 m2 (Schwartz formula-abbreviated).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 106
- •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
排除标准
- •exclusion criteria at baseline:
- •1- Recipients of kidneys from donors with known renal disease (such as diabetic nephropathy, nephrosclerosis), at the time of transplant.
- •2 - Recipients of a kidney with a cold ischemia time > 24 hours.
- •3 - History of hypersensitivity or contraindications to any of the study drugs or to drugs of similar chemical classes, or to any of the excipients.
- •4 - History of malignancy of any organ system treated or untreated, carrying possible risk of recurrence according to current guidelines (Appendix 10).
- •other protocol-defined exclusion criteria may apply
- •Exclusion criteria at Randomization (4-6 weeks after transplantation)
- •1 - Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives prior randomization, whichever is longer.
- •2 - Patients with ongoing or recently (within 2 weeks prior to randomization) treated episodes of acute rejection (any grade) or a steroid resistant acute rejection at the time of randomization.
- •3 - Patients who experienced acute cellular rejection (Banff =1B) or any antibody mediated acute rejection or patients considered at high risk of antibody mediated acute rejection by the investigator assessment (e.g. presence of newly formed DSA, histological suspicion) at any time before randomization (as the DSA quantitative threshold to define high risk is not fully established, the assessment of the risk will be made after discussion between the laboratory expert and the investigator who will take into account all information available and apply best judgment).
- •4 - Patients with ongoing wound healing problems, clinically significant wound infection requiring continued therapy or other severe surgical complication in the opinion of the investigator.
- •5 - Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) and can not discontinue the treatment (see Appendix 6 for list of medications).
- •6 - Patients with nephrotic range proteinuria (protein to creatinine ratio =2.0 mg/mg or 200 mg/mmol.
- •other protocol-defined exclusion criteria may apply
研究者
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进行中（未招募）
不适用
Efficacy, tolerability and safety of early introduction of everolimus, reduced calcineurin inhibitors and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients.EUCTR2010-024381-21-Outside-EU/EEAovartis Pharma Services AG106
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