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OpenTrials
Completed

NCT Number: NCT02358980

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

KIDNEY therapy

Device

Primary outcomes

  1. Independence of haemodialysis at 3 months from enrollment

    Time frame: 3 months from enrollment

Secondary outcomes

  1. Efficency of KIDNEY therapy system with respect to reduced sFLC levels

    Time frame: 21 days from enrollment

  2. Duration of HD from renal recover

    Time frame: 3 months from enrollment

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Acronym: KEEPER

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2015
Registry last updated
Jun 25, 2025

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.

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