Clinical trial NCT05429515: Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury
Official title: Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Multiple Myeloma
Acute Kidney Injury
Hemodiafiltration With Ultrafiltrate Regeneration (HFR)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Bellco Hoxen Medical (Shanghai) Co., Ltd
First posted: 2022-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: independence from dialysis at 90 days from allocation to groups
timeFrame: 90 days after allocation to groups
Secondary outcomes:
measure: independence from dialysis at 6 months from allocation to groups
timeFrame: 6 months after allocation to groups
measure: complete renal recovery at 90 days from allocation to groups
timeFrame: 90 days after allocation to groups
measure: decline of free light chain at 21 days from allocation to groups
timeFrame: 21 days after allocation to groups
measure: hematological remission at 90 days from allocation to groups
timeFrame: 90 days after allocation to groups
measure: hematological remission at 6 months from allocation to groups
timeFrame: 6 months after allocation to groups
measure: time to independence from dialysis
timeFrame: from allocation to groups to the last time of Hemodialysis or HFR-SUPRA
measure: survival at 12 months
timeFrame: 12 months after allocation to groups
measure: adverse events
timeFrame: within the 3 months after allocation to groups
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yan Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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