Acute Kidney Injury, Cast Nephropathy, Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Cast Nephropathy, Acute kidney injury, KIDNEY THERAPY, HFR
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.
Interventions
DEVICEKIDNEY therapy
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Independence of haemodialysis at 3 months from enrollment | 3 months from enrollment |
Secondary
| Measure | 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 |
Countries
Italy
Outcome results
None listed