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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:
Participants are recruited by one of the following methods:
Participant visits the prescreening website.
Study team contacts potential participants to review the study and explain next steps
Participant is provided with the link and password to view the video and sign the consent via Adobe Sign
An investigator will meet virtually with the participant to obtain medical history information, concomitant medications, and performance status (screening visit)
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
The lab will fax results to the site
After review of eligibility and the study team will proceed with enrolling the participant if appropriate
The participant will proceed to the baseline visit (telehealth for any portion that can be done via phone/video and order for lab tests as previously described) if needed to comply with the protocol calendar/window.
The participant is approved to begin dosing by the investigator
The site will dispense via mail the following:
Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary
If clinically indicated, labs will be ordered and run more frequently to assess for toxicity.
Visits 3, 4, and 5 will be conducted in the same manner as described above.
All pill bottles and diaries (if paper version is used) will be returned via the provided envelope
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg orally, daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 10mg orally once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving 30% reduction in daily proteinuria. | A patient will be considered to have achieved the desired urine protein reduction if a 30% reduction in 24-hour albuminuria occurs at any point during the six-month period from the initiation of dapagliflozin therapy. The proportion of patients achieving this reduction will be calculated as the ratio of the total number of patients who experienced the reduction to the total number of evaluable patients. | Up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of tele-visits | The completion rate of tele-visits, including post-trial feedback, will be calculated as the ratio of completed tele-visits to scheduled tele-visits. | Up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing any of the following: (1) sustained decline in eGFR, (2) onset of ESRD, or (3) death from a renal disease-related or cardiovascular cause. | A patient's status will be recorded as 'yes' if any of the following three events occur at any time during the 6 months of study therapy: a sustained ≥50% decline in estimated glomerular filtration rate (eGFR); the onset of dialysis-requiring end- stage renal disease (ESRD); or death from a renal disease-related or cardiovascular cause. Otherwise, the status will be marked as 'no'. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane Houde | Contact | 3135768673 | Houdec@karmanos.org | |
| Jeffrey Zonder, M.D. | Contact | 3135768732 | zonderj@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Zonder, M.D. | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Up to Month 6 |
| Incidence rate of developing dialysis dependent ESRD in patients with Pavia Renal AL Stage II or III involvement. | The onset of ESRD in patients with Pavia Renal Stage II or III involvement will be recorded as binary (yes vs. no). | Up to Month 6 |