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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01531751 |
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Date of registration:
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11/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease
DIACAL |
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Scientific title:
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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. |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01531751 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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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 ?/? 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Primary Amyloidosis of Light Chain Type
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Intervention(s)
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Drug: Chemotherapy
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Device: High Cut-off Hemodialysis
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Primary Outcome(s)
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Survival
[Time Frame: 6 months]
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Secondary Outcome(s)
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tolerability of the experimental device
[Time Frame: 1 month]
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Secondary ID(s)
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AC-005-IT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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