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NCT06420167 · ClinicalTrials.gov registry record · Phase 2
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
A Phase 2 study of Renal AL Amyloidosis, sponsored by Barbara Ann Karmanos Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06420167: Recruiting Phase 2 study of Renal AL Amyloidosis, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT06420167 is a Phase 2 study of Renal AL Amyloidosis that is actively recruiting participants, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06420167, a Phase 2 study of Renal AL Amyloidosis, is actively recruiting participants, sponsored by Barbara Ann Karmanos Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dapagliflozin
Study Locations (1)
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What NCT06420167 shows while recruiting
NCT06420167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Renal AL Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which Dapagliflozin is the first listed.
NCT06420167 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06420167 about?
NCT06420167 is a clinical study titled "DapagliFLOzin in Renal AL Amyloidosis (FLORAL)". 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 plat...
What is the current status of trial NCT06420167?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-07-11. Estimated completion is 2027-04.
What conditions does trial NCT06420167 study?
This clinical trial studies the following conditions: Renal AL Amyloidosis.
What interventions are being tested in trial NCT06420167?
The interventions under investigation include: Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT06420167?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06420167 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06420167's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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