EUCTR2010-024381-21-DE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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •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 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 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
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study at
- •1. Recipients of kidneys from donors with known renal disease (such as diabetices
- •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 halflives
- •of enrollment, whichever is longer.
- •4.3. History of hypersensitivity or contraindication to any of the study drugs or to drugs of
- •similar chemical classes, or to any of the excipients.
- •5.4. History of malignancy of any organ system treated or untreated, carrying possible risk
- •of recurrence according to current guidelines (Appendix 10). within the past 5 years,
- •regardless of whether there is evidence of local recurrence or metastases.
- •6.5. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state
- •of a female after conception and until the termination of gestation, confirmed by a
- •positive hCG laboratory test (> 9 mIU/mL).
- •7.6. Female patients of child-bearing potential, defined as all women physiologically
- •capable of becoming pregnant, UNLESS they agree for to abstinence from sexual activity.
- •8.7. Patients who are recipients of multiple solid organ transplants, including dual and en
- •bloc kidneys, or who have previously received transplanted organs except a primary
- •kidney transplant.
- •9.8. Recipient of kidneys from HLA-identical living related donors.
- •This document (090095a8846f511b in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI.
- •Signatures manifested as of 3/4/2013 8:16:30 AM, signing status at this time: Completed (1 of 1 signatures)
- •Approved for report publication by Martzloff El-Djouher in Basel at Mon, Mar 04, 2013 09:16:13 CET
- •Novartis Confidential Page 28
- •Amended Protocol Version v02 track changes Protocol CRAD001A2314
- •10.9. Recipients of kidneys from donors who are greater than 60 years or younger than 5
- •11.10. Recipient of ABO incompatible allograft or a positive T cell cross-match.
- •12.11. Most recent anti-HLA Class I/II panel reactive antibodies > 20 % by a Complement
- •Dependent Cytotoxicity (CDC)-based assay or > 50% by a flow cytometry or Enzyme
- •Linked Immunosorbent Assay (ELISA)-based assay.
- •13.12. Patients considered at high risk of antibody mediated acute rejection (e.g. presence of
- •pre-formed DSA) (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).
- •14.13. Patient who is human immunodeficiency virus (HIV) positive or Hepatitis C (PCR
- •only) or B surface antigen positive. Viral serology
研究者
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