Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury

Phase 4Not Yet RecruitingNCT05429515

Peking Union Medical College Hospital50 enrolled

Overview

In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Acute Kidney Injury Hemodiafiltration With Ultrafiltrate Regeneration (HFR)

Interventions

HFR-SUPRAPROCEDURE

HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.

hemodialysisPROCEDURE

hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.

ChemotherapyDRUG

chemotherapy protocol will be made by hematologists.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

independence from dialysis at 90 days from allocation to groups

Time frame: 90 days after allocation to groups

Secondary Outcomes

independence from dialysis at 6 months from allocation to groups

Time frame: 6 months after allocation to groups

complete renal recovery at 90 days from allocation to groups

serum creatinine elevation≤ 0.2 mg/dl from baseline or serum creatinine ≤ 1.2 mg/dl if baseline level is unknown

Time frame: 90 days after allocation to groups

decline of free light chain at 21 days from allocation to groups

decline of free light chain from baseline level

Time frame: 21 days after allocation to groups

hematological remission at 90 days from allocation to groups

Time frame: 90 days after allocation to groups

hematological remission at 6 months from allocation to groups

Time frame: 6 months after allocation to groups

time to independence from dialysis

Time frame: from allocation to groups to the last time of Hemodialysis or HFR-SUPRA

Central Contacts

SanXi Ai, MD

CONTACT

18811054896 sanxiai@163.com

Yan Qin, MD

CONTACT

13718706171 qinyanbeijing@126.com

Data from ClinicalTrials.gov

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