KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Independence of haemodialysis at 3 months from enrollment
研究概览
简要总结
Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal recovery in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.
This study will evaluate patients with multiple myeloma and severe renal failure treated with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.
详细描述
This is an observational study performed to investigate the clinical benefit of FLC removal by KIDNEY therapy system in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in July 2014, in total 20 patients will be recruited. Participants will be treated with, KIDNEY therapy system (Bellco Mirandola, Modena, Italy) . The KIDNEY system is a kind of haemodiafiltration that utilizes separated convection, diffusion and adsorption. The sorbent cartridge has a high affinity for FLC (both κ and λ) but is able to re-infuse albumin, avoiding the need for albumin perfusions. The KIDNEY therapy will be undertaken over an intensive treatment schedule. The primary outcome for the study is independence of dialysis in 3 month. Secondary outcomes are: duration dialysis, reduction of serum FLC levels, myeloma response and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Dialysis dependent acute renal failure
- •Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma
- •Abnormal serum FLC ratio and a sFLC concentration > 500 mg/L
- •Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
- •Ability to give informed consent to partake in study
- •Commencement of study within 10 days of presenting to enrolling unit
排除标准
- •Known advanced chronic renal failure (CKD stage IV 4-5; eGFR <30mls/min/1.73m2) or evidence of significant chronic damage on renal biopsy
- •Amyloidosis or light chain deposition disease on renal biopsy
- •Previous treatment of multiple myeloma with chemotherapy
- •Haemodynamic instability that precludes unsupported dialysis renal replacement therapy
- •Significant cardiac disease
- •Active uncontrolled infection
- •Inability to give informed consent
结局指标
主要结局
Independence of haemodialysis at 3 months from enrollment
时间窗: 3 months from enrollment
次要结局
- Duration of HD from renal recover(3 months from enrollment)
- Efficency of KIDNEY therapy system with respect to reduced sFLC levels(21 days from enrollment)