Kidney Therapy for Free Light Chain Removal in Patients W... | NCT02358980

Studies
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy

NCT02358980

Sponsor

Azienda USL Reggio Emilia - IRCCS

Status

Completed

Last Update Posted

Jun 25, 2025Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Multiple Myeloma
Cast Nephropathy
Acute Kidney Injury

Interventions

KIDNEY therapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2015Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Feb 4, 2015

First Submission Date that Met QC Criteria

Feb 6, 2015

First Posted Date

Feb 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal recovery in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.

This study will evaluate patients with multiple myeloma and severe renal failure treated with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.

Detailed Description

This is an observational study performed to investigate the clinical benefit of FLC removal by KIDNEY therapy system in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in July 2014, in total 20 patients will be recruited. Participants will be treated with, KIDNEY therapy system (Bellco Mirandola, Modena, Italy) . The KIDNEY system is a kind of haemodiafiltration that utilizes separated convection, diffusion and adsorption. The sorbent cartridge has a high affinity for FLC (both κ and λ) but is able to re-infuse albumin, avoiding the need for albumin perfusions. The KIDNEY therapy will be undertaken over an intensive treatment schedule. The primary outcome for the study is independence of dialysis in 3 month. Secondary outcomes are: duration dialysis, reduction of serum FLC levels, myeloma response and survival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Participants will receive FLC removal HD undertaken using an extended dialysis schedule on KIDNEY therapy system. Treatments (4 hours each) were carried out for 8 consecutive days and then every other day.	Device: KIDNEY therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KIDNEY therapy	Device		Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Independence of haemodialysis at 3 months from enrollment		3 months from enrollment

Secondary Outcomes

Measure	Description	Time Frame
Efficency of KIDNEY therapy system with respect to reduced sFLC levels		21 days from enrollment
Duration of HD from renal recover		3 months from enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years
Dialysis dependent acute renal failure
Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma
Abnormal serum FLC ratio and a sFLC concentration > 500 mg/L
Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
Ability to give informed consent to partake in study
Commencement of study within 10 days of presenting to enrolling unit

Exclusion Criteria:

Known advanced chronic renal failure (CKD stage IV 4-5; eGFR <30mls/min/1.73m2) or evidence of significant chronic damage on renal biopsy
Amyloidosis or light chain deposition disease on renal biopsy
Previous treatment of multiple myeloma with chemotherapy
Haemodynamic instability that precludes unsupported dialysis renal replacement therapy
Significant cardiac disease
Active uncontrolled infection
Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nephrology and Dialysis Unit ASMN IRCCS		Reggio Emilia	Reggio Emilia	42123	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8569099	Result	Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.
16396976	Result	Haubitz M, Peest D. Myeloma--new approaches to combined nephrological-haematological management. Nephrol Dial Transplant. 2006 Mar;21(3):582-90. doi: 10.1093/ndt/gfi318. Epub 2006 Jan 5. No abstract available.

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D009101	Multiple Myeloma
D058186	Acute Kidney Injury