Chronic Kidney Disease Stage 4Fluo-AKINCT06760650
Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease
A study testing Fluorescein angiography in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 3B, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 5
- What is being tested?
- Fluorescein angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Jan 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR<45 mL/min/1.73 m2)
Who cannot join
- Patients who do not give their consent
- Patients who are allergic to fluorescein
- Patients who are on dialysis
- Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention
- Patients who had a treatment modification one week before the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anthony NOHRA, Medical Student contact
Lebanon1 site
Faculty of Medicine, Saint Joseph University of Beirut
Beirut, 56100
Mabel AOUN, M.D., M.P.H., +9613351588, aounmabel@yahoo.fr
Dania CHELALA, M.D., dania.chelala@hotmail.com
About this study
Official title: Fluorescein-Induced Acute Kidney Injury in Patients With Diabetes and Chronic Kidney Disease
Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.
Read the detailed description
This study will assess the change in serum creatinine in patients with diabetes and advanced chronic kidney disease, after a fluorescein angiography. This is a before and after study that will include 35 patients from the department of ophtalmology over 6 months with a total follow-up for 3 months.
- Conditions
- Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 5, Diabetes Mellitus, Fluorescein Angiography, Acute Kidney Injury
- Being tested
- Fluorescein angiography
- Keywords
- Fluorescein Angiography, Acute kidney injury, Chronic kidney disease, Diabetes
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein angiographyDiagnostic test
Also called Fluorescein fundus angiography
Fluorescein angiography
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein angiography | Experimental | Assessing serum creatinine before and after fluorescein angiography Receives: Diagnostic Test: Fluorescein angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine
Change in serum creatinine from baseline to day 4
Measured: At day 4
Secondary outcomes (1)
Long-term change in serum creatinine
Change in serum creatinine from baseline to end of the third month
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mabel Aoun, Saint-Joseph University
- Investigators
- Mabel AOUN, M.D., M.P.H., Principal investigator, Faculty of Medicine, Saint Joseph University of Beirut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760650
- Sponsor's protocol ID
- CEHDF 2587
- Other IDs
- Tfem-2025-79
- Acronym
- Fluo-AKI
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescein-Induced Acute Kidney Injury in Patients With Diabetes and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06760650
- Acronym / sponsor ID
- Fluo-AKI / CEHDF 2587
- Conditions
- Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease Stage 5, Diabetes Mellitus, Fluorescein Angiography, Acute Kidney Injury
- Keywords
- Fluorescein Angiography, Acute kidney injury, Chronic kidney disease, Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.
Detailed description
This study will assess the change in serum creatinine in patients with diabetes and advanced chronic kidney disease, after a fluorescein angiography. This is a before and after study that will include 35 patients from the department of ophtalmology over 6 months with a total follow-up for 3 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescein angiography | Experimental | Diagnostic Test: Fluorescein angiographyAssessing serum creatinine before and after fluorescein angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR<45 mL/min/1.73 m2)
Key exclusion criteria (5 listed)
- Patients who do not give their consent
- Patients who are allergic to fluorescein
- Patients who are on dialysis
- Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention
- Patients who had a treatment modification one week before the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescein angiographyAlso: Fluorescein fundus angiographyFluorescein angiography | Diagnostic test | Fluorescein angiography |
Primary outcome
Change in serum creatinine
Time frame: At day 4
Change in serum creatinine from baseline to day 4
1 secondary outcome
Long-term change in serum creatinine
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony NOHRA, Medical Student contact
Mabel AOUN, M.D., M.P.H. principal investigator
Faculty of Medicine, Saint Joseph University of Beirut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescein angiography in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 3B, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mabel AOUN, M.D., M.P.H. (+9613351588, aounmabel@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine (time frame: At day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.