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NCT Number: NCT07235891

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

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.

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Key information

Conditions

Retinal Nerve Fiber Layer Thickness Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University

Alexandria, 21532, Egypt

Location contact

Ahmed A. El-Masry, Prof.

PRINCIPAL_INVESTIGATOR

Ahmed F. El-Keraie, Prof.

PRINCIPAL_INVESTIGATOR

Ahmed F. El-Yazbi, Prof.

PRINCIPAL_INVESTIGATOR

Labiba K. El-Khordagui, Prof.

PRINCIPAL_INVESTIGATOR

Merna M. AbouKhatwa

CONTACT

[email protected]

+201115966255

Merna M. AbouKhatwa, Assistant Lecturer

PRINCIPAL_INVESTIGATOR

Noha A. Hamdy, Assoc. Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retinal protection

    Time frame: 6 months

    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.

Secondary outcomes

  1. CKD progression

    Time frame: 6 months

    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).

  2. Safety assessment (Number of patients with adverse events)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Investigating the Impact of Finerenone on Retinal Vascular Dysfunction in Patients With Chronic Kidney Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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