Retinal Nerve Fiber Layer ThicknessPhase 4NCT07235891
Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease
A Phase 4 study testing Finerenone in people with Retinal Nerve Fiber Layer Thickness and Chronic Kidney Disease, run by Alexandria University at 1 site in Egypt.
Trial summary
Interestingly, A hypothesis-generating analysis was conducted from two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR), suggesting a potential benefit of finerenone in the delay of progression of non-proliferative diabetic retinopathy (NPDR), independent of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Nerve Fiber Layer Thickness, Chronic Kidney Disease
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to 20 Mar 2027
- Phase
- Phase 4
- 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
- Age: above 18 years
- Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).
Who cannot join
- Patients on hemodialysis (HD).
- Serum potassium level > 5.5 mEq/L
- Prior/planned ocular interventions (retinal laser treatment, intravitreal injection or vitrectomy).
- Pregnant and lactating women
- Malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Alexandria University
Alexandria, 21532
Merna M. AbouKhatwa, +201115966255, merna.abokhatwa@alexu.edu.eg
Labiba K. El-Khordagui, Prof.
About this study
Official title: Investigating the Impact of Finerenone on Retinal Vascular Dysfunction in Patients With Chronic Kidney Disease
Interestingly, A hypothesis-generating analysis was conducted from two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR), suggesting a potential benefit of finerenone in the delay of progression of non-proliferative diabetic retinopathy (NPDR), independent of baseline HbA1c. Potential benefits of finerenone were also observed in the prevention of required ocular interventions. However, the studies relied on routine ophthalmological examinations done retrospectively, which may have affected data quality and certainly affected quantity. Hence, there is a compelling need to conduct randomized studies with adequate power to detect a potential benefit of finerenone in delaying retinopathy progression, particularly given the lack of alternative options for oral treatment of retinopathy.
Read the detailed description
An Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial to elucidate the difference in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings; OCT metrics include macular thickness, retinal thickness, choroidal thickness, macular ganglion cell-inner plexiform layer and retinal nerve fiber layer (RNFL) thickness.
- According to literature, patients with chronic kidney disease have choroidal and retinal thinning compared to matched healthy volunteers, that's why it is interesting to investigate the potential benefit of finerenone on their retinal metrics.
Both study groups (treatment group) and (control group) will undergo ocular examinations (OCT and field of vision) in addition to blood and urine samples to be obtained at baseline, and at different follow up periods (1 month, 3 months and 6 months).
- Delta changes in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings and also between groups will be measured.
Additionally,
- Mean change from baseline scores of routine laboratory investigations of CKD patients including serum creatinine, urea, uric acid, urinary Albumin to creatinine ratio (ACR).
- Mean change from baseline values of metabolic parameters including random blood glucose (RBG), glycated hemoglobin (HbA1C), lipid profile and liver enzymes (ALT and AST). In addition to mean change in body weight.
- To examine the metabolic regulatory effects exhibited by finerenone by measuring the mean change from baseline levels of adipokine leptin.
- Being tested
- Finerenone
- Keywords
- Retinal dysfunction, Finerenone, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Finerenone, a novel orally administered selective non-steroidal MRA demonstrates stronger affinity to the mineralocorticoid receptor (MR) in comparison with eplerenone and spironolactone resulting in better efficacy in aldosterone's inhibition.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (Finerenone) | Experimental | Treatment arm: will receive oral Finerenone in addition to standard treatment.
Initial dose of finerenone will be determined according to eGFR:
eGFR>= 60 mL/min: 20 mg once daily. eGFR>25 mL/min, <60 mL/min: 10 mg once daily eGFR<15 mL/min: use is contraindicated Maintenance dose will be determined by the serum potassium level measured 4 weeks after initiation of therapy or dose adjustment according to CKD progression Receives: Drug: Finerenone |
| Control arm | No intervention | Control arm: will receive standard treatment according to patient's condition and symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal protection
To elucidate the difference in retinal nerve fiber layer (RNFL) thickness (measured in micro meters) measured by optical coherence tomography (OCT) after treatment initiation compared to baseline findings measured by the same device and assessed by the same operator.
Measured: 6 months
Secondary outcomes (2)
CKD progression
Mean change from baseline scores of full renal profile of CKD patients including serum creatinine (mg/dL), urea (mg/dL), uric acid (mg/dL), urinary albumin to creatinine ratio (ACR) (mg/g) and serum albumin (g/dL).
Measured: 6 months
Safety assessment (Number of patients with adverse events)
Safety will be assessed at all scheduled visits by measuring the serum potassium level. Hyperkalemia is an adverse event of special interest in this study. Serum potassium (mmol/L) and hyperkalemia will be characterized through monitoring the change from baseline in serum potassium and identification of the number of patients with serum potassium levels >5.5 mmol/L and >6.0 mmol/L.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Nerve Fiber Layer ThicknessStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Abou Khatwa, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235891
- Sponsor's protocol ID
- 0202162
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Finerenone on Retinal Vascular Dysfunction in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07235891
- Acronym / sponsor ID
- 0202162
- Keywords
- Retinal dysfunction, Finerenone, Chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 19 Nov 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.
Interestingly, A hypothesis-generating analysis was conducted from two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR), suggesting a potential benefit of finerenone in the delay of progression of non-proliferative diabetic retinopathy (NPDR), independent of baseline HbA1c. Potential benefits of finerenone were also observed in the prevention of required ocular interventions. However, the studies relied on routine ophthalmological examinations done retrospectively, which may have affected data quality and certainly affected quantity. Hence, there is a compelling need to conduct randomized studies with adequate power to detect a potential benefit of finerenone in delaying retinopathy progression, particularly given the lack of alternative options for oral treatment of retinopathy.
Detailed description
An Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial to elucidate the difference in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings; OCT metrics include macular thickness, retinal thickness, choroidal thickness, macular ganglion cell-inner plexiform layer and retinal nerve fiber layer (RNFL) thickness.
- According to literature, patients with chronic kidney disease have choroidal and retinal thinning compared to matched healthy volunteers, that's why it is interesting to investigate the potential benefit of finerenone on their retinal metrics.
Both study groups (treatment group) and (control group) will undergo ocular examinations (OCT and field of vision) in addition to blood and urine samples to be obtained at baseline, and at different follow up periods (1 month, 3 months and 6 months).
- Delta changes in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings and also between groups will be measured.
Additionally,
- Mean change from baseline scores of routine laboratory investigations of CKD patients including serum creatinine, urea, uric acid, urinary Albumin to creatinine ratio (ACR).
- Mean change from baseline values of metabolic parameters including random blood glucose (RBG), glycated hemoglobin (HbA1C), lipid profile and liver enzymes (ALT and AST). In addition to mean change in body weight.
- To examine the metabolic regulatory effects exhibited by finerenone by measuring the mean change from baseline levels of adipokine leptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (Finerenone) | Experimental | Drug: FinerenoneTreatment arm: will receive oral Finerenone in addition to standard treatment. Initial dose of finerenone will be determined according to eGFR: eGFR>= 60 mL/min: 20 mg once daily. eGFR>25 mL/min, <60 mL/min: 10 mg once daily eGFR<15 mL/min: use is contraindicated Maintenance dose will be determined by the serum potassium level measured 4 weeks after initiation of therapy or dose adjustment according to CKD progression |
| Control arm | No intervention | –Control arm: will receive standard treatment according to patient's condition and symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: above 18 years
- Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).
Key exclusion criteria (5 listed)
- Patients on hemodialysis (HD).
- Serum potassium level > 5.5 mEq/L
- Prior/planned ocular interventions (retinal laser treatment, intravitreal injection or vitrectomy).
- Pregnant and lactating women
- Malignancy
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 |
|---|---|---|
| FinerenoneFinerenone, a novel orally administered selective non-steroidal MRA demonstrates stronger affinity to the mineralocorticoid receptor (MR) in comparison with eplerenone and spironolactone resulting in better efficacy in aldosterone's inhibition. | Drug | Intervention arm (Finerenone) |
Primary outcome
Retinal protection
Time frame: 6 months
To elucidate the difference in retinal nerve fiber layer (RNFL) thickness (measured in micro meters) measured by optical coherence tomography (OCT) after treatment initiation compared to baseline findings measured by the same device and assessed by the same operator.
2 secondary outcomes
CKD progression
Time frame: 6 months
Safety assessment (Number of patients with adverse events)
Time frame: 6 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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone in people with Retinal Nerve Fiber Layer Thickness and Chronic Kidney Disease, run by Alexandria University at 1 site in Egypt.
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 2 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 19 Nov 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal protection (time frame: 6 months). 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 19 Nov 2025.