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

Sponsor
Alexandria University
Study ID
NCT07235891
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Sep 2025
Primary completion
Dec 20, 2026
Completion
Mar 20, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • No Intervention: Control arm
    Control arm: will receive standard treatment according to patient's condition and symptoms.

Primary Outcome Measure

Retinal protection [ Time Frame: 6 months ]

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