High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Di… (NCT01531751) | Clinical Trial Compass
WithdrawnPhase 2
High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease
Italy0Started 2015-02
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Survival
Timeframe: 6 months
Trial details
NCT IDNCT01531751
SponsorFondazione IRCCS Policlinico San Matteo di Pavia