NCT06420167 DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
| NCT ID | NCT06420167 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Barbara Ann Karmanos Cancer Institute |
| Condition | Renal AL Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-07-11 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile/web applications for study purposes. * Age ≥18 years. * Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of \>1.0 g/day proteinuria without any other identifiable cause. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. * Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician. * Residence in the state of Michigan. Exclusion Criteria: * Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for \<6 months prior to enrollment. * Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past. * Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding. * Known allergic reactions to components of the dapagliflozin. * Treatment requiring type 1 or type 2 diabetes mellitus. * Baseline eGFR \<25 mL/min/1.73m2. * Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy) * Current or previous use of any SGLT2i. * Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) \<3 months prior to enrollment. * Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers).
Contact & Investigator
Jeffrey Zonder, M.D.
PRINCIPAL INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Frequently Asked Questions
Who can join the NCT06420167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal AL Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06420167 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06420167 currently recruiting?
Yes, NCT06420167 is actively recruiting participants. Contact the research team at Houdec@karmanos.org for enrollment information.
Where is the NCT06420167 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT06420167 clinical trial?
NCT06420167 is sponsored by Barbara Ann Karmanos Cancer Institute. The principal investigator is Jeffrey Zonder, M.D. at Barbara Ann Karmanos Cancer Institute. The trial plans to enroll 20 participants.