Assessment of Rituximab Therapeutic Response Versus Conventional Treatment in the Management of Refractory Nephrotic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- The effectiveness of either conventional therapy alone or Rituximab as an add on therapy will be assessed by measure of Remission sate of the patient.
研究概览
简要总结
Prospective interventional comparative study to compare the efficacy of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome including patients on triple immunosuppression protocols.
详细描述
A prospective randomized controlled interventional study, conducted on Refractory Nephrotic syndrome patients with failed different lines of conventional treatment.
The aim of the current study is to assess the therapeutic response of Rituximab versus Conventional treatment in Refractory Nephrotic Syndrome in terms of :
- Improvement in proteinuria.
- Relapse frequency.
Fourty patients with Refractory Nephrotic syndrome will be enrolled in the study. All participants will be previously treated with ACEi and/or ARB, for ≥3 months prior to randomization and adequate blood pressure control. Participants will be assigned randomly into two groups with 20 Refractory Nephrotic syndrome patients in each group as follow:
- Group (1) RTX in Refractory Nephrotic syndrome patients on conventional treatment (20 patients)
- Group (2) Refractory Nephrotic Syndrome patients on Conventional therapy (20 patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult ≥ 18 year old and medically stable.
- •Treatment with an Angiotension converting enzyme inhibitor (ACEi) and/or Angiotension II receptor blockade (ARB), for ≥3 months prior to randomization and adequate blood pressure control or if patient is intolerant to even a very low dose of either ACEi or ARB therapy.
- •Proteinuria ≥3 g/24 h using the average from two 24-hour urine collections collected within 14 days of each other despite ARB for ≥3 months as described above.
- •Estimated GFR ≥40 ml/min/1.73 m2 while taking ACEi/ARB therapy or quantified endogenous creatinine clearance ≥40 ml/min based on a 24 h urine collection.
- •Non responsive GN patients on conventional treatment.
排除标准
- •Autoimmune diseases.
- •Patients with presence of active infection or a secondary cause of IMN (e.g. hepatitis B, SLE, medications, malignancies).
- •Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.
- •Pregnancy or breast feeding.
- •Predisposition to drug hypersensitivity.
- •Unstable medical condition.
研究组 & 干预措施
RTX in Refractory Nephrotic syndrome patients on conventional treatment
Refratory Nephrotic syndrome participants will receive a 375 mg/m2 weekly rituximab for four doses, with retreatment every 2 months till 6 months regardless of proteinuria response in addition to triple optimized immunosuppression therapy including steroids ± Calcineurine inhibitors (CNI) (e.g: Tacrolimus), Mycophenloatemofetil (MMF) and Cyclophosphamide (CTX)
干预措施: Rituximab (Drug)
RTX in Refractory Nephrotic syndrome patients on conventional treatment
Refratory Nephrotic syndrome participants will receive a 375 mg/m2 weekly rituximab for four doses, with retreatment every 2 months till 6 months regardless of proteinuria response in addition to triple optimized immunosuppression therapy including steroids ± Calcineurine inhibitors (CNI) (e.g: Tacrolimus), Mycophenloatemofetil (MMF) and Cyclophosphamide (CTX)
干预措施: Dexamethasone (Drug)
Refractory Nephrotic Syndrome patients on Conventional therapy
Nephrotic syndrome participants will receive conventional therapy treatment only including steroids ± Tacrolimus (TAC), Cyclosporine (CsA), Mycophenloatemofetil (MMF), and Cyclophosphamide (CTX) then if become refractory to conventional treatment will continue on the same treatment.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The effectiveness of either conventional therapy alone or Rituximab as an add on therapy will be assessed by measure of Remission sate of the patient.
时间窗: 6 months
The primary end point is Complete or Partial remission at 6 months after randomization. Complete remission (CR) is defined as UP ≤0.3 g/24 h and serum albumin ≥3.5 g/dl while Partial remission (PR) is defined as Reduction in baseline UP of ≥50% plus final UP ≤3.5 g/24 h but \>0.3 g/24 h. The patient who will be Non-responsive to therapy is defined as Reduction in baseline UP of \<25% (includes increase in UP) after 6 months of immunosuppression and the patient who will enter in the relapsed phase is defined as development of nephrotic range proteinuria following CR or PR, i.e. \>3.5 g/24 h.
次要结局
- A) Late Remissions:(6, 9, and 12 months after randomization.)
- B) Relapse state:(12 months after randomization)
- C) Response Treatment Time:(12 months after randomization)
- D) End Stage Renal Disease (ESRD):(12 months after randomization)
- E) Renal Function:(6 months after randomization)
- F) Adverse events:(6, 9, and 12 months after randomization.)
研究者
shaymaa omar
Head of clinical pharmacy department at Dar Al Fouad hospital
Ain Shams University