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

June 19, 2022 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Chemotherapy
chemotherapy protocol will be made by hematologists.
Procedure: hemodialysis
hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days after allocation to groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after allocation to groups
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
90 days after allocation to groups
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
21 days after allocation to groups
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
90 days after allocation to groups
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 months after allocation to groups
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
from allocation to groups to the last time of Hemodialysis or HFR-SUPRA
survival at 12 months
Time Frame: 12 months after allocation to groups
survival at 12 months
12 months after allocation to groups
adverse events
Time Frame: within the 3 months after allocation to groups
adverse events
within the 3 months after allocation to groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Bellco Hoxen Medical (Shanghai) Co., Ltd

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2032

Study Completion (Anticipated)

December 1, 2032

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFR_MM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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