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

ConditionsRetinal Nerve Fiber Layer ThicknessChronic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention arm (Finerenone)Experimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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).

Time frame
6 months
2

Safety assessment (Number of patients with adverse events)

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: