Chronic Kidney Disease, Retinal Nerve Fiber Layer Thickness
Conditions
Keywords
Retinal dysfunction, Finerenone, Chronic kidney disease
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.
Detailed description
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.
Interventions
DRUGFinerenone
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal protection | 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
| Measure | Time frame | Description |
|---|---|---|
| CKD progression | 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). |
| Safety assessment (Number of patients with adverse events) | 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. |
Countries
Egypt
Outcome results
None listed