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

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
HFR-SUPRA
hemodialysis
Chemotherapy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HFR-SUPRA

    Hemodialysis

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    independence from dialysis at 90 days from allocation to groups
    independence from dialysis at 90 days from allocation to groups

    Secondary Outcome Measures

    independence from dialysis at 6 months from allocation to groups
    independence from dialysis at 6 months from 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
    decline of free light chain at 21 days from allocation to groups
    decline of free light chain from baseline level
    hematological remission at 90 days from allocation to groups
    hematological remission at 90 days from allocation to groups
    hematological remission at 6 months from allocation to groups
    hematological remission at 6 months from allocation to groups
    time to independence from dialysis
    time to independence from dialysis
    survival at 12 months
    survival at 12 months
    adverse events
    adverse events

    Full Information

    First Posted
    June 19, 2022
    Last Updated
    June 19, 2022
    Sponsor
    Peking Union Medical College Hospital
    Collaborators
    Bellco Hoxen Medical (Shanghai) Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05429515
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2032 (Anticipated)
    Study Completion Date
    December 1, 2032 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital
    Collaborators
    Bellco Hoxen Medical (Shanghai) Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma, Acute Kidney Injury, Hemodiafiltration With Ultrafiltrate Regeneration (HFR)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HFR-SUPRA
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Hemodialysis
    Arm Type
    Active Comparator
    Arm Description
    hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week.
    Intervention Type
    Procedure
    Intervention Name(s)
    HFR-SUPRA
    Other Intervention Name(s)
    haemodiafiltration with ultrafiltrate regeneration by adsorption on resin
    Intervention Description
    HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.
    Intervention Type
    Procedure
    Intervention Name(s)
    hemodialysis
    Intervention Description
    hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Intervention Description
    chemotherapy protocol will be made by hematologists.
    Primary Outcome Measure Information:
    Title
    independence from dialysis at 90 days from allocation to groups
    Description
    independence from dialysis at 90 days from allocation to groups
    Time Frame
    90 days after allocation to groups
    Secondary Outcome Measure Information:
    Title
    independence from dialysis at 6 months from allocation to groups
    Description
    independence from dialysis at 6 months from allocation to groups
    Time Frame
    6 months after allocation to groups
    Title
    complete renal recovery at 90 days from allocation to groups
    Description
    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
    Title
    decline of free light chain at 21 days from allocation to groups
    Description
    decline of free light chain from baseline level
    Time Frame
    21 days after allocation to groups
    Title
    hematological remission at 90 days from allocation to groups
    Description
    hematological remission at 90 days from allocation to groups
    Time Frame
    90 days after allocation to groups
    Title
    hematological remission at 6 months from allocation to groups
    Description
    hematological remission at 6 months from allocation to groups
    Time Frame
    6 months after allocation to groups
    Title
    time to independence from dialysis
    Description
    time to independence from dialysis
    Time Frame
    from allocation to groups to the last time of Hemodialysis or HFR-SUPRA
    Title
    survival at 12 months
    Description
    survival at 12 months
    Time Frame
    12 months after allocation to groups
    Title
    adverse events
    Description
    adverse events
    Time Frame
    within the 3 months after allocation to groups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    SanXi Ai, MD
    Phone
    18811054896
    Email
    sanxiai@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Qin, MD
    Phone
    13718706171
    Email
    qinyanbeijing@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Qin, MD
    Organizational Affiliation
    Peking Union Medical College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury

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