High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo

Criteria

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.