Investigating the Impact of Finerenone on Retinal Vascular Dysfunction in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retinal protection
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: above 18 years
- •Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).
排除标准
- •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
研究组 & 干预措施
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
干预措施: Finerenone (Drug)
结局指标
主要结局
Retinal protection
时间窗: 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.
次要结局
- CKD progression(6 months)
- Safety assessment (Number of patients with adverse events)(6 months)
研究者
Merna Abou Khatwa
Assistant Lecturer
Alexandria University