JPRN-jRCT1051210189招募中未知
A single-arm pilot study to evaluate changes in renal function and safety of steroid pulse therapy in renal transplant patients with advanced tertiary lymphoid tissues
Yanagita Motoko0 个研究点目标入组 30 人开始时间: 2022年3月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •For primary enrollment, the following criteria must be met
- •1) Patients who have undergone living donor kidney transplantation in Japan
- •2) Patients scheduled to undergo protocol renal biopsy 1 year after kidney transplantation
- •3) 18 to 75 years old, and at the time of consent/enrollment date
- •4) Written consent has been obtained from the patient for study participation.
- •For secondary enrollment, the following criterion must be met
- •1) Positive Advanced tertiary lymphoid tissues on renal biopsy 1 year after kidney transplantation
排除标准
- •Patients will be excluded from primary enrollment if they meet any of the following criteria
- •1) Prior treatment with rituximab from perioperative to study enrollment
- •2) No improvement in renal function after kidney transplantation (eGFR < 30 ml/min/1.73 m2 ) until study enrollment
- •3) Previous diagnosis of BK virus nephropathy within 1 year after kidney transplant
- •4) Pathologically diagnosed with acute rejection within 1 year of kidney transplant
- •5) Patients who have received another organ transplant
- •6) Patients suffering from serious infections and other serious complications
- •7) Patients with poorly controlled diabetes mellitus (HbA1c >= 7.5%)
- •8) Patients with poorly controlled glaucoma
- •9) Patients with poorly controlled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >= 100 mmHg)
- •10) Obesity (BMI >= 40 kg/m2)
- •11) History of fracture due to osteoporosis
- •12) History of severe drug allergy to steroids.
- •13) Women who are pregnant or may become pregnant. Women who are lactating.
- •Patients will be excluded from secondary enrollment if they meet any of the following criteria
- •1) Diagnosis of acute rejection by renal biopsy 1 year after kidney transplantation.
- •2) Diagnosis of BK virus nephropathy by renal biopsy 1 year after kidney transplantation
- •3) Diagnosis of nephritis or other lesions requiring therapeutic intervention by renal biopsy 1 year after kidney transplantation
- •4) Patients who are judged unsuitable to conduct this study by the principal investigator or sub-investigator.
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