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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05429515
Collaborator
Bellco Hoxen Medical (Shanghai) Co., Ltd (Other)
50
Enrollment
2
Arms
125
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysisPatients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury: a Prospective Cohort Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2032
Anticipated Study Completion Date :
Dec 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: HFR-SUPRA
HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.
Other Names:
  • haemodiafiltration with ultrafiltrate regeneration by adsorption on resin

    • Drug: Chemotherapy
    chemotherapy protocol will be made by hematologists.
    Active Comparator: Hemodialysis

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

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

    Drug: Chemotherapy
    chemotherapy protocol will be made by hematologists.

    Outcome Measures

    Primary Outcome Measures

    1. independence from dialysis at 90 days from allocation to groups [90 days after allocation to groups]

      independence from dialysis at 90 days from allocation to groups

    Secondary Outcome Measures

    1. independence from dialysis at 6 months from allocation to groups [6 months after allocation to groups]

      independence from dialysis at 6 months from allocation to groups

    2. complete renal recovery at 90 days from allocation to groups [90 days after allocation to groups]

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

    3. decline of free light chain at 21 days from allocation to groups [21 days after allocation to groups]

      decline of free light chain from baseline level

    4. hematological remission at 90 days from allocation to groups [90 days after allocation to groups]

      hematological remission at 90 days from allocation to groups

    5. hematological remission at 6 months from allocation to groups [6 months after allocation to groups]

      hematological remission at 6 months from allocation to groups

    6. time to independence from dialysis [from allocation to groups to the last time of Hemodialysis or HFR-SUPRA]

      time to independence from dialysis

    7. survival at 12 months [12 months after allocation to groups]

      survival at 12 months

    8. adverse events [within the 3 months after allocation to groups]

      adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • Bellco Hoxen Medical (Shanghai) Co., Ltd

    Investigators

    • Principal Investigator: Yan Qin, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05429515
    Other Study ID Numbers:
    • HFR_MM
    First Posted:
    Jun 23, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jun 23, 2022