Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease

NCT ID: NCT07235891

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2027-03-20

Brief 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 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.

Conditions

Retinal Nerve Fiber Layer Thickness; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm (Finerenone)

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

Group Type: EXPERIMENTAL

Finerenone

Intervention Type: 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.

Control arm

Control arm: will receive standard treatment according to patient's condition and symptoms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Finerenone

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: above 18 years
• Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Merna Abou Khatwa

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexandria University

Alexandria, , Egypt

Countries

Egypt

Facility Contacts

Merna M. AbouKhatwa

Role: primary

merna.abokhatwa@alexu.edu.eg

+201115966255

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

0202162

Identifier Type: -

Identifier Source: org_study_id