EUCTR2010-024381-21-BE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
- 性别
- All
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 paediatric kidney transplant greater than or equal to 1 year
- •and younger than 18 years receiving a primary 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 > 50 ml/min/1.73 m2 (Schwartz formulaabbreviated).
- •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
- •diabetes nephropathy, nephrosclerosis), at the time of transplant.
- •2 - Recipients of a kidney with a cold ischemia time > 24 hours.
- •3 - Use of other investigational drugs at the time of enrollment, or within
- •30 days or 5 half-lives of enrollment, whichever is longer.
- •4 - History of hypersensitivity or contraindications to any of the study
- •drugs or to drugs of similar chemical classes, or to any of the excipients.
- •5 - History of malignancy of any organ system treated or untreated,
- •within the past 5 years, regardless of whether there is evidence of local
- •recurrence or metastases.
- •other protocol-defined exclusion criteria may apply
- •Exclusion criteria at Randomization (4-6 weeks after transplantation)
- •1 - Patients with ongoing or currently treated episodes of acute rejection
- •(any grade) or a steroid resistant acute rejection at the time of
- •randomization.
- •2 - 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).
- •3 - Patients with ongoing wound healing problems, clinically significant
- •wound infection requiring continued therapy or other severe surgical
- •complication in the opinion of the investigator.
- •4 - 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).
- •5 - 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
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Pediatric patients that received a transplanted kidney will receive immunosuppressive medication-the calcineurin inhibitor (tacrolimus) and antiproliferative agent (MMF)-until they will be randomized between week 4 and 6 to receive either the same treatment or to switch to the investigational drug everolimus. The patients will be followed up until 3 years after transplantation to evaluate the efficacy, tolerability and safety of the treatments and to assess their impact on renal function.EUCTR2010-024381-21-ESovartis Farmacéutica, S.A.106
进行中（未招募）
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Pediatric patients that received a transplanted kidney will receive immunosuppressive medication-the calcineurin inhibitor (tacrolimus) and antiproliferative agent (MMF)-until they will be randomized between week 4 and 6 to receive either the same treatment or to switch to the investigational drug everolimus. The patients will be followed up until 3 years after transplantation to evaluate the efficacy, tolerability and safety of the treatments and to assess their impact on renal function.Prevention of acute rejection in paediatric recipients of a renal transplantMedDRA version: 19.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-024381-21-GBovartis Pharma Services AG106