Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
DapagliFLOzin in Renal AL Amyloidosis FLORAL
Sponsor:
Jeffrey Zonder
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
DapagliFLOzin in Renal AL Amyloidosis FLORAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
FLORAL
Brief Summary:
The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain AL amyloidosis using a decentralized study design
Participants will be
screened for the trial via an online platform
contacted by study personal to obtain electronic consent
enrolled in the trial if eligible and consented
contacted by study personal for further instructions and directions
sent dapagliflozin oral medication supplied by the site pharmacy
followed up regularly with the study team via telemedicine or other online avenues
monitored using lab work inquiries about side effects and assessment of protocol adherence at 1 month 3 months and 6 months
continue treatment for 6 months
Participants will be
screened for the trial via an online platform
contacted by study personal to obtain electronic consent
enrolled in the trial if eligible and consented
contacted by study personal for further instructions and directions
sent dapagliflozin oral medication supplied by the site pharmacy
followed up regularly with the study team via telemedicine or other online avenues
monitored using lab work inquiries about side effects and assessment of protocol adherence at 1 month 3 months and 6 months
continue treatment for 6 months
Detailed Description:
1 Participants are recruited by one of the following methods
1 Self-referral through the website
2 Receiving recruitment materials from their provider
2 Participant visits the prescreening website
1 High level prescreening questions are answered by the participant
2 If appropriate based on answers to the questions the participant may provide their contact information for follow up by the study team
3 Study team contacts potential participants to review the study and explain next steps
4 Participant is provided with the link and password to view the video and sign the consent via Adobe Sign
5 An investigator will meet virtually with the participant to obtain medical history information concomitant medications and performance status screening visit
6 Once the participant passes screening in step 5 an order will be sent to the participant for the remaining screening labs to be done at a local laboratory that is covered by their insurance
7 The lab will fax results to the site
8 After review of eligibility and the study team will proceed with enrolling the participant if appropriate
9 The participant will proceed to the baseline visit telehealth for any portion that can be done via phonevideo and order for lab tests as previously described if needed to comply with the protocol calendarwindow
10 The participant is approved to begin dosing by the investigator
11 The site will dispense via mail the following
1 4 months supply of Dapagliflozin
2 A self-addressed envelope for return of the diary and pill bottles at the end of the dosing period
3 A weighing scale if required
12 Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary
13 If clinically indicated labs will be ordered and run more frequently to assess for toxicity
14 Visits 3 4 and 5 will be conducted in the same manner as described above
15 All pill bottles and diaries if paper version is used will be returned via the provided envelope
1 Self-referral through the website
2 Receiving recruitment materials from their provider
2 Participant visits the prescreening website
1 High level prescreening questions are answered by the participant
2 If appropriate based on answers to the questions the participant may provide their contact information for follow up by the study team
3 Study team contacts potential participants to review the study and explain next steps
4 Participant is provided with the link and password to view the video and sign the consent via Adobe Sign
5 An investigator will meet virtually with the participant to obtain medical history information concomitant medications and performance status screening visit
6 Once the participant passes screening in step 5 an order will be sent to the participant for the remaining screening labs to be done at a local laboratory that is covered by their insurance
7 The lab will fax results to the site
8 After review of eligibility and the study team will proceed with enrolling the participant if appropriate
9 The participant will proceed to the baseline visit telehealth for any portion that can be done via phonevideo and order for lab tests as previously described if needed to comply with the protocol calendarwindow
10 The participant is approved to begin dosing by the investigator
11 The site will dispense via mail the following
1 4 months supply of Dapagliflozin
2 A self-addressed envelope for return of the diary and pill bottles at the end of the dosing period
3 A weighing scale if required
12 Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary
13 If clinically indicated labs will be ordered and run more frequently to assess for toxicity
14 Visits 3 4 and 5 will be conducted in the same manner as described above
15 All pill bottles and diaries if paper version is used will be returned via the provided envelope
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None