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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2032-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HFR-SUPRA

Intervention Type PROCEDURE

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

Chemotherapy

Intervention Type DRUG

chemotherapy protocol will be made by hematologists.

Hemodialysis

hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.

Group Type ACTIVE_COMPARATOR

hemodialysis

Intervention Type PROCEDURE

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

Chemotherapy

Intervention Type DRUG

chemotherapy protocol will be made by hematologists.

Interventions

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HFR-SUPRA

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

Intervention Type PROCEDURE

hemodialysis

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

Intervention Type PROCEDURE

Chemotherapy

chemotherapy protocol will be made by hematologists.

Intervention Type DRUG

Other Intervention Names

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haemodiafiltration with ultrafiltrate regeneration by adsorption on resin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No