Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01531751
Status:
WITHDRAWN
Last Update Posted:
2018-03-21
First Post:
2012-01-11
Brief Title:
High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIACAL
Brief 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
Detailed Description:
This will be a single-center phase II open label trial Subjects with advanced cardiac AL amyloidosis and end-stage renal disease will undergo HCO-HD while receiving chemotherapy for their plasma cell dyscrasia according to the current standards of care
After giving written informed consent the patients will be evaluated for eligibility Briefly the subjects with a biopsy-proven diagnosis of AL amyloidosis who are cardiac stage 3 based on NT-proBNP 332 ngL and cTnI 100 ngL and whose estimated glomerular filtration rate eGFR is 15 mLmin per 173 m2 will be eligible for the study Patients with non-AL eg familial and senile amyloidosis will be excluded as well as subjects who have less than 100 mgL circulating amyloidogenic FLC Sixteen patients will be enrolled
The study includes 3 periods screening treatment followed by the end-of-treatment evaluation and follow-up During dialysis the patients will undergo the first cycle of chemotherapy according to the current standard of care for subjects with advanced cardiac AL amyloidosis Measurements of FLC and cardiac biomarkers will be done before and after each dialysis session High cutoff HD will be continued during the first chemotherapy cycle After the first cycle the end-of-treatment evaluation will take place Follow-up evaluations will be performed after the end of each subsequent chemotherapy cycle and every 2 months after chemotherapy discontinuation for 1 year or until disease progression occurs
After giving written informed consent the patients will be evaluated for eligibility Briefly the subjects with a biopsy-proven diagnosis of AL amyloidosis who are cardiac stage 3 based on NT-proBNP 332 ngL and cTnI 100 ngL and whose estimated glomerular filtration rate eGFR is 15 mLmin per 173 m2 will be eligible for the study Patients with non-AL eg familial and senile amyloidosis will be excluded as well as subjects who have less than 100 mgL circulating amyloidogenic FLC Sixteen patients will be enrolled
The study includes 3 periods screening treatment followed by the end-of-treatment evaluation and follow-up During dialysis the patients will undergo the first cycle of chemotherapy according to the current standard of care for subjects with advanced cardiac AL amyloidosis Measurements of FLC and cardiac biomarkers will be done before and after each dialysis session High cutoff HD will be continued during the first chemotherapy cycle After the first cycle the end-of-treatment evaluation will take place Follow-up evaluations will be performed after the end of each subsequent chemotherapy cycle and every 2 months after chemotherapy discontinuation for 1 year or until disease progression occurs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None