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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Procedure: hemodialysis; Procedure: HFR-SUPRA; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05429515

HFR_MM

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

HFR-SUPRA

Experimental group

Description:

haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week.

Treatment:

Drug: Chemotherapy

Procedure: HFR-SUPRA

Hemodialysis

Active Comparator group

Description:

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

Treatment:

Drug: Chemotherapy

Procedure: hemodialysis