Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021
研究概览
简要总结
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups.
Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.
Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
详细描述
Chronic kidney disease (CKD) is defined by a reduction in the kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months). It varies depending on the amount of blood pressure control, the degree of proteinuria, the previous rate of decline in GFR, and the underlying renal disease, including diabetes.
Phosphorus excretion decreases in many kidney disorders, and as a result, the amount of fibroblast growth factor 23 (FGF-23) rises.FGF-23 levels have appeared to predict risk of death in individuals with chronic renal disease as the estimated glomerular filtration rate declines, and a corresponding increase in FGF-23 can be noted.
FGF-23 is a hormone with a molecular weight of 30 kDa works on fibroblast growth factor receptors (FGFR1-4) in the kidney, heart, colon, and parathyroid gland. It is secreted by osteocytes and, to a lesser extent by osteoblasts into the bloodstream. A rise in FGF-23 could indicate kidney dysfunction, and concurrent bone disease. Patients with CKD are well known to have greater risk for developing bone fractures.
The term "chronic kidney disease-mineral bone disorder" (CKD-MBD) refers to the decline in bone quality and the subsequent development of disorders in bone and mineral metabolism caused by impaired kidney function. In addition to PTH, vitamin D, calcium and phosphorus, fibroblast growth factor-23 (FGF-23) play a role in CKD-MBD.
Treatment of the underlying disease, if possible, and treatment of secondary factors, such as increased blood pressure and proteinuria, are the two main ways to limit the rate of CKD progression. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are renin-angiotensin system (RAS) inhibitors that are more effective than other antihypertensive medications in reducing proteinuria and slowing the rate of progression of proteinuria during CKD, regardless of the etiology.
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
- Double (Participant, Investigator)
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 ≥ 18 years old.
- •Both sexes.
- •Patients matched in the duration of CKD.
- •Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b).
- •Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
- •Patients with serum Potassium < 5 mEq/L.
- •A newly diagnosed patients with hypertension.
- •Exclusion criteria:
- •Patients with elevated level of potassium ≥ 5 mEq/L.
- •Patients with diabetes.
- •Patients with cancer.
- •Patients with heart disease.
- •Patients with hepato-biliary disease and other liver diseases.
- •Patients with kidney stones and urinary tract infection.
- •Patients with an overactive thyroid gland.
- •Patients with bleeding disorder.
- •History of drug allergy to ACEI or ARBs.
- •Pregnant and breastfeeding women.
- •Patients with blood pressure ≥180/110 or <100/
- •Patients on alteplase, azothiopurine, everolimus, sirolimus, lithium, non-steroidal anti-inflammatory drugs (epifenac, tenoxicam, Celecoxib....), potassium retentive diuretics (amiloride, spironolactone), other ACEIs and ARBs will be excluded to avoid possible drug-drug interactions with ramipril.
- •Patients on omega-3 fatty acids; vitamins (especially A, C, E, K), Chemotherapy and oral anticoagulant (warfarin), cholestyramine, orlistate will be excluded to avoid possible drug interactions that could affect Coenzyme Q10
排除标准
- 未提供
研究组 & 干预措施
Group 1: Control group
Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
干预措施: Placebo (Drug)
Group 2: Coenzyme Q10
Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day.The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
干预措施: Co-Enzyme Q10 (Drug)
结局指标
主要结局
The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021
时间窗: The study duration will be 6 months.
Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021.
The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g)
时间窗: The study duration will be 6 months
Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g)
The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer
时间窗: The study duration will be 6 months
Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks.
The change in Blood urea nitrogen (BUN) (mg/dl)
时间窗: The study duration will be 6 months
Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum potassium (meq/l).
时间窗: The study duration will be 6 months
Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum creatinine (mg/dl)
时间窗: The study duration will be 6 months
Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum urea (mg/dl)
时间窗: The study duration will be 6 months
Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
次要结局
- The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)(The study duration will be 6 months.)
- The change in I-PTH (pg/ml)(The study duration will be 6 months)
- The change in vitamin D level (ng/ml)(The study duration will be 6 months)
- The change in serum calcium level (mg/dl)(The study duration will be 6 months)
- The change in serum phosphorus level (mg/dl)(The study duration will be 6 months.)
- Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire(The study duration will be 6 months)
研究者
Dina Zaki Mohamed Zaki Abdel Hamid
Clinical Pharmacist
Tanta University