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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this trial

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.

Eligibility criteria

Qualifiers

Age: above 18 years

Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Finerenone

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators