Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control arm | No Intervention | Control arm: will receive standard treatment according to patient's condition and symptoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Safety assessment (Number of patients with adverse events) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | 21532 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2025 | Sep 27, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C576501 | finerenone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 6 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |