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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05429515
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Peking Union Medical College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yan Qin, MD
Principal Investigator Affiliation Peking Union Medical College Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

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.

Active Comparator: Hemodialysis

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

Interventions

Procedure: - HFR-SUPRA

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

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

SanXi Ai, MD

sanxiai@163.com

18811054896

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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