Clinical trial · Interventional
High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease
An Open Label Phase II Trial of Free Light Chain Removal by Extended High Cut-Off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End-Stage Renal Disease.
NCT01531751CI-TRIAL-00032168DIACALwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Amyloidosis of Light Chain Type | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| High Cut-off Hemodialysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Cut-off Hemodialysis
- interventionNames
- Device: High Cut-off Hemodialysis
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 6 months
- description
- The primary objective will be to assess survival of patients with advanced cardiac AL amyloidosis treated with HCO-HD combined with chemotherapy.
Secondary outcomes (1)
- measure
- tolerability of the experimental device
- timeFrame
- 1 month
- description
- Secondary objectives will be to assess the feasibility and tolerability of HCO-HD in patients with advanced cardiac AL amyloidosis, the efficiency of HCO-HD plus chemotherapy in reducing amyloidogenic FLC in this setting, and the ability of this approach to promote improvement of cardiac dysfunction as assessed by biomarkers.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of AL amyloidosis. * Age ≥ 18 years. * Evidence of a monoclonal light chain in serum and/or urine by positive immunofixation and abnormal FLC κ/λ ratio. * Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \> 12 mm in the absence of other causes). * Cardiac stage III (both NT-proBNP \> 332 ng/L and cTnI \> 100 ng/L). * Estimated GFR \< 15 mL/min per 1.73 m2 or requiring dialysis. * NYHA class III or IV. * Initiation of chemotherapy for AL amyloidosis scheduled between day 3 and day 8 after first HCO-HD session. Exclusion Criteria: * Non-AL (e.g. familial, senile) amyloidosis. * Concomitant non-amyloid related clinically significant cardiac diseases. * Involved (amyloidogenic) FLC \< 100 mg/L. * Inability to undergo chemotherapy for AL amyloidosis. * Uncontrolled infection. * Inability to give informed consent. * Previous or ongoing psychiatric illness (excluding reactive depression). * Pregnant or nursing women.
References
Publications (1)
- BACKGROUNDHutchison 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 17229909