A Randomized Controlled Trial Of Rituximab As Induction Therapy In Living Donor Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This will be a prospective, single-center randomized controlled trial evaluating Rituximab as induction therapy in living donor renal transplantation.
It will include 60 adult patients (1:1 allocation) undergoing first ABO-compatible, DSA-negative transplant.
The rationale is that de novo donor-specific antibodies (DSA) contribute to rejection and graft loss, and rituximab may prevent this via B-cell depletion.
The intervention arm will receive a single dose of rituximab 375 mg/m² IV 7–21 days before transplant, while the control arm will not receive induction therapy.
All patients will receive standard triple immunosuppression with tacrolimus, mycophenolate mofetil, and steroids.
Primary outcomes will be de novo DSA formation and graft survival at 12 months.
Secondary outcomes will include acute rejection, patient survival, graft function, infections, adverse effects, and hospitalizations.
DSA will be measured using Luminex single antigen assay.
Patients will be followed up at 1, 3, 6, 9, and 12 months with clinical and laboratory monitoring.
Ethics approval, informed consent, and necessory formalities will be ensured.
The hypothesis is that rituximab reduces de novo DSA and improves graft outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients over 18 years receiving their first ABO compatible living donor renal transplant 2.Negative CDC less than 10 percentage of flow crossmatch 3.Negative baseline DSA with MFI less than 1000 by Luminex SAB assay Written informed consent.
排除标准
- 未提供
研究者
DrAnjali Patel
Muljibhai Patel Urological Hospital, Nadiad