Acute Kidney Injury, Hemodiafiltration With Ultrafiltrate Regeneration (HFR), Multiple Myeloma
Conditions
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.
Interventions
PROCEDUREHFR-SUPRA
HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.
PROCEDUREhemodialysis
hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.
DRUGChemotherapy
chemotherapy protocol will be made by hematologists.
Sponsors
Bellco Hoxen Medical (Shanghai) Co., Ltd
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 90 days from allocation to groups | 90 days after allocation to groups | hematological remission at 90 days from allocation to groups |
| 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 |
| 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 |
| hematological remission at 6 months from allocation to groups | 6 months after allocation to groups | hematological remission at 6 months from allocation to groups |
Contacts
Primary ContactSanXi Ai, MD
Backup ContactYan Qin, MD
Outcome results
None listed