2025-525091-29-00招募中2 期
SISTAR: Stratifying Immunosuppression to Allogenic Risk. A randomized, open label, assessor blinded, controlled, non-inferiority, safety study of half- vs standard dose immunosuppression in kidney transplant recipients with a well-matched donor.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Biopsy-proven rejection (Banff ≥1A) within the one-year intervention phase (V5-V17)
研究概览
简要总结
To show the safety of halving maintenance IS in kidney transplant recipients that are of low allogenic risk
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipient
- •Transplanted with a deceased donor kidney transplant within the last three months
- •18 years of age or older
- •Tacrolimus-based immunosuppression
- •CCRS category 1 or 4 (low or high risk respectively)
排除标准
- •Multi organ transplant recipient
- •Unable to sign the informed consent
- •Recipient is Epstein–Barr virus (EBV) sero-negative
- •Recipient is cytomegalovirus (CMV) sero-negative and receives an organ from a CMV positive donor
- •Active hepatitis B/C infection
- •DSA MFI>1000
- •Recipient has been a participant of a trial less than three months before enrolment
- •CCRS category 2 or 3 (moderate low or moderate high risk respectively)
- •Biopsy-proven rejection Banff ≥1A
研究组 & 干预措施
NULOJIX 250 mg powder for concentrate for solution for infusion
Test
干预措施: NULOJIX 250 mg powder for concentrate for solution for infusion (Drug)
结局指标
主要结局
Biopsy-proven rejection (Banff ≥1A) within the one-year intervention phase (V5-V17)
Biopsy-proven rejection (Banff ≥1A) within the one-year intervention phase (V5-V17)
Occurrence of dnDSAs (MFI>1000) within the one-year intervention phase (V5-V17)
Occurrence of dnDSAs (MFI>1000) within the one-year intervention phase (V5-V17)
次要结局
- eGFR levels after the one-year intervention phase
- Incidence of ddcfDNA > 1% within the one-year intervention phase
- Graft loss within the one-year intervention phase: Graft loss is defined as permanent (>3 months) return to dialysis or re-transplantation.
- Incidence rate of infections within the one-year intervention phase
- Mortality within the one-year intervention phase
研究者
Division of Nephrology and Dialysis, Department of Medicine III
Scientific
Medical University Of Vienna
研究点 (1)
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