NCT02358980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

February 18, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

February 4, 2015

Last Update Submit

June 20, 2025

Conditions

Multiple MyelomaCast NephropathyAcute Kidney Injury

Keywords

Multiple MyelomaCast NephropathyAcute kidney injuryKIDNEY THERAPYHFR

Outcome Measures

Primary Outcomes (1)

  • Independence of haemodialysis at 3 months from enrollment

    3 months from enrollment

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

KIDNEY therapyDEVICE
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology and Dialysis Unit ASMN IRCCS

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

Related Publications (6)

  • Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.

    PMID: 8569099BACKGROUND

  • 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.

    PMID: 16396976BACKGROUND

  • Hutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappell MJ, Cook M, Goehl H, Storr M, Bradwell AR. Efficient removal of immunoglobulin free light chains by hemodialysis for multiple myeloma: in vitro and in vivo studies. J Am Soc Nephrol. 2007 Mar;18(3):886-95. doi: 10.1681/ASN.2006080821. Epub 2007 Jan 17.

    PMID: 17229909BACKGROUND

  • Hutchison CA, Blade J, Cockwell P, Cook M, Drayson M, Fermand JP, Kastritis E, Kyle R, Leung N, Pasquali S, Winearls C; International Kidney and Monoclonal Gammopathy Research Group. Novel approaches for reducing free light chains in patients with myeloma kidney. Nat Rev Nephrol. 2012 Feb 21;8(4):234-43. doi: 10.1038/nrneph.2012.14.

    PMID: 22349488BACKGROUND

  • Testa A, Dejoie T, Lecarrer D, Wratten M, Sereni L, Renaux JL. Reduction of free immunoglobulin light chains using adsorption properties of hemodiafiltration with endogenous reinfusion. Blood Purif. 2010;30(1):34-6. doi: 10.1159/000316684. Epub 2010 Jun 24.

    PMID: 20588010BACKGROUND

  • Pasquali S, Iannuzzella F, Corradini M, Mattei S, Bovino A, Stefani A, Palladino G, Caiazzo M. A novel option for reducing free light chains in myeloma kidney: supra-hemodiafiltration with endogenous reinfusion (HFR). J Nephrol. 2015 Apr;28(2):251-4. doi: 10.1007/s40620-014-0130-8. Epub 2014 Aug 23.

    PMID: 25149172BACKGROUND

MeSH Terms

Conditions

Multiple MyelomaAcute Kidney Injury

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

February 18, 2015

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

IT(1)