Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05429515

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Multiple Myeloma Acute Kidney Injury Blood Protein Disorders Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemodiafiltration With Ultrafiltrate Regeneration (HFR) Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Kidney Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFR-SUPRA

Procedure

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

hemodialysis

Procedure

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

Chemotherapy

Drug

chemotherapy protocol will be made by hematologists.

Primary outcomes

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

    Time frame: 90 days after allocation to groups

    independence from dialysis at 90 days from allocation to groups

Secondary outcomes

  1. independence from dialysis at 6 months from allocation to groups

    Time frame: 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

    Time frame: 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

    Time frame: 21 days after allocation to groups

    decline of free light chain from baseline level

  4. hematological remission at 90 days from allocation to groups

    Time frame: 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

    Time frame: 6 months after allocation to groups

    hematological remission at 6 months from allocation to groups

  6. time to independence from dialysis

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

    time to independence from dialysis

  7. survival at 12 months

    Time frame: 12 months after allocation to groups

    survival at 12 months

  8. adverse events

    Time frame: within the 3 months after allocation to groups

    adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

SanXi Ai, MD

CONTACT

[email protected]

18811054896

Yan Qin, MD

CONTACT

[email protected]

13718706171

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Bellco Hoxen Medical (Shanghai) Co., Ltd

Registry information

Official study title

Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury: a Prospective Cohort Study

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jun 23, 2022
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.