NL-OMON24720已完成4 期
MOdifying Tacrolimus related TOxicity after liver transplantation (MOTTO). A randomized controlled trial comparing Envarsus® versus Advagraf® in de novo liver transplant recipients
Stichting Lever en Maag Darm onderzoek, Erasmus MC0 个研究点目标入组 106 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
Significantly less liver transplant recipients reached the composite primary endpoint at 12 months in the LCP-tacrolimus group compared to the extended-release tacrolimus group (50.9%, 95%-CI 37.9% - 63.9% versus 71.2%, 95%-CI 57.7% - 81.7%, p=0.005). This significant difference was observed both in the intention-to-treat and in the per protocol analysis. No differences in rejection rate, graft and patient survival were found. In conclusion, LCP-tacrolimus has a more favorable cardiovascular risk profile and results in less chronic kidney disease as compared to ER-tacrolimus in the first year after liver transplantation with comparable efficacy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- First liver transplantation
- •- Age between 18 and 75
排除标准
- •- Pregnancy or breast feeding
- •- eGFR < 30 mL/min/1.73m2
研究者
相似试验
进行中(未招募)
1 期
Envarsus® will be compared with the current standard treatment Advagraf® after liver transplantation.EUCTR2018-002856-34-NLFoundation for Liver research106
已完成
4 期
Modifying tacrolimus related toxicity after liver transplantation. A randomized controlled trial comparing Envarsus® and Advagraf® in de novo liver transplant recipients.NL-OMON55491Stichting Leveronderzoek106
已完成
2 期
Envarsus XL Immunosuppression Following Liver TransplantationRecipients of Liver TransplantNCT03828058Methodist Healthcare110
招募中
4 期
Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release FormulationsLiver TransplantationImmunosuppressionNeurotoxicityTremorTacrolimusNCT05089604University of British Columbia124
尚未招募
4 期
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.Liver TransplantationNCT06147648Beijing Tsinghua Chang Gung Hospital352
