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

NCT07235891 | Not Yet Recruiting Phase 4

• 1 other identifier: 0202162
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Nerve Fiber Layer Thickness; Chronic Kidney Disease

Keywords

Retinal dysfunction; Finerenone; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• CKD progression

  6 months

• Safety assessment (Number of patients with adverse events)

  6 months

Study Arms (2)

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

Drug: Finerenone

Control arm

NO INTERVENTION

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

Interventions

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.

Intervention arm (Finerenone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 21532, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)