Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury
- Conditions
- Hemodiafiltration With Ultrafiltrate Regeneration (HFR)Multiple MyelomaAcute Kidney Injury
- Interventions
- Procedure: HFR-SUPRAProcedure: hemodialysisDrug: Chemotherapy
- Registration Number
- NCT05429515
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.
- Detailed Description
In patients with multiple myeloma-related severe acute kidney injury, compare the renal outcome between patients receiving HFR-SUPRA and patients receiving hemodialysis. Both groups of patients receive chemotherapy.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 18 to 80 years old
- new onset of multiple myeloma
- acute kidney injury with eGFR < 15 ml/min/1.73m2 and need hemodialysis
- biopsy-proven cast nephropathy or clinical diagnosis of cast nephropathy based on exclusion of other causes of acute kidney injury including post-renal obstruction, hypercalcaemia, amyloidosis, light-chain deposition disease, contrast media and drug nephropathy
- serum light chain > 500 mg/L
- chronic kidney disease stage 3 to 5 (eGFR< 60 ml/min/1.73m2 for at least 3 months)
- haemodynamics unstability
- active bleeding
- cardiovascular and cerebrovascular events in the last month
- other malignant tumor
- conditions not suitable to participate in the study, such as bad compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemodialysis Chemotherapy hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week. HFR-SUPRA Chemotherapy haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week. HFR-SUPRA HFR-SUPRA haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week. Hemodialysis hemodialysis hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.
- Primary Outcome Measures
Name Time Method independence from dialysis at 90 days from allocation to groups 90 days after allocation to groups independence from dialysis at 90 days from allocation to groups
- Secondary Outcome Measures
Name Time Method complete renal recovery at 90 days from allocation to groups 90 days after allocation to groups serum creatinine elevation≤ 0.2 mg/dl from baseline or serum creatinine ≤ 1.2 mg/dl if baseline level is unknown
independence from dialysis at 6 months from allocation to groups 6 months after allocation to groups independence from dialysis at 6 months from allocation to groups
hematological remission at 90 days from allocation to groups 90 days after allocation to groups hematological remission at 90 days from allocation to groups
decline of free light chain at 21 days from allocation to groups 21 days after allocation to groups decline of free light chain from baseline level
hematological remission at 6 months from allocation to groups 6 months after allocation to groups hematological remission at 6 months from allocation to groups
time to independence from dialysis from allocation to groups to the last time of Hemodialysis or HFR-SUPRA time to independence from dialysis
survival at 12 months 12 months after allocation to groups survival at 12 months
adverse events within the 3 months after allocation to groups adverse events