Effects of Calcitriol on Podocytes in Diabetic Kidney Disease Patients: Assessment of Urine Podocin, Urine Nephrin, Urine Interleukin-6, Urine KIM-1, Plasma Renin, and Albuminuria
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urinary podocin
研究概览
简要总结
Diabetic Kidney Disease (DKD) is a complication that occurs due to poor glycemic control over a long period. The decrease or loss of podocytes is an important index in determining the degree of glomerular damage. Previous studies in patients with DKD reported that vitamin D administration can improve their renal function through several mechanisms. However, there is still little evidence available regarding the effects of calcitriol on biomarkers of DKD. This trial is a double-blind randomized controlled trial to assess the effect of calcitriol in DKD patients through several biomarkers which reflect pathomechanism in DKD. Those biomarkers include urinary podocin, urinary nephrin, urinary KIM-1, urinary IL-6, plasma renin, and albuminuria.
The primary outcome is any improvement on podocyte markers, tubular markers, kidney inflammation parameters, plasma renin, and albuminuria between calcitriol and placebo groups. Secondary outcomes include the relation between each marker and the side effects of intervention therapy.
详细描述
Diabetic Kidney Disease (DKD) is a complication that occurs due to poor glycemic control over a long period. The decrease or loss of podocytes is an important index in determining the degree of glomerular damage. Albuminuria and estimated glomerular filtration rate (eGFR) are currently used as the marker of DKD. However, these markers may not directly measure renal tissue injury. Thus, investigating novel biomarkers, particularly podocyte-associated biomarkers, is needed to predict DKD. Previous studies in patients with DKD reported that vitamin D administration can improve their renal function. of the various types of vitamin D, there is still little evidence available regarding the effects of calcitriol on biomarkers of DKD. Therefore, this study aimed to determine the effect of calcitriol on podocyte damage markers, tubular injury markers, kidney inflammation parameter, plasma renin, dan albuminuria in DKD patients.
This study is a double-blind randomized controlled clinical trial to assess the effect of calcitriol in DKD patients through several markers including albuminuria. Podocyte damage is characterized by urinary podocin and urinary nephrin, tubular marker injury is characterized by urinary KIM-1, kidney inflammation is represented by urinary IL-6, hemodynamic is represented by plasma renin.
The primary outcome is any improvement on those markers between calcitriol and placebo groups. And the secondary outcomes include the relation between each marker and the side effects of intervention therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Controlled type 2 diabetes mellitus with HbA1C at least <8% and albuminuria (UACR>30 mg/mmol)
- •Estimated Glomerular Filtration Rate (eGFR) >45 ml/min/1.73 m2
- •Agree to participate in the research
排除标准
- •Uncontrolled hypertension with routine Angiotensin-converting-enzyme inhibitors (ACEi) or Angiotensin II receptor blockers (ARBs) treatment
- •Hypercalcemia (total serum Ca level >10/5 mg/dL)
- •Hyperphosphatemia (total serum phosphate level >5 mg/dL)
- •Hypersensitivity to calcitriol
- •Suffering from other diseases that cause proteinuria
- •Acute diseases
- •Smoker or previous smoking history
- •Taking medications or suplements that can affect calcitriol metabolism (thiazide, digoxin, anti-convulsant)
研究组 & 干预措施
Intervention Group
Drug: Calcitriol The intervention group will be given calcitriol at a dose of 0.25 mcg/day for six months in the form of capsules that have been marked and numbered. The drugs will be taken through the RSCM pharmacy once a month during visit and the allocation will be given using drug labels that are sealed and packaged identically.
干预措施: Calcitriol capsules (Drug)
Placebo Group
Drug: Placebo oral The placebo drug will be given for six months in the form of capsules that have been marked and numbered. The drugs will be taken through the RSCM pharmacy once a month during visit and the allocation will be given using drug labels that are sealed and packaged identically.
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary podocin
时间窗: 6 months
Marker of podocyte injury, will be measured before, during, and after treatment
Urinary nephrin
时间窗: 6 months
Marker of podocyte injury, will be measured before, during, and after treatment
Plasma renin
时间窗: 6 months
Marker of hemodynamic pathway, will be measured before, during, and after treatment
Albuminuria
时间窗: 6 months
Marker of glomerular damage, will be measured before, during, and after treatment
Urinary KIM-1
时间窗: 6 months
Marker of tubular injury, will be measured before, during, and after treatment
Urinary IL-6
时间窗: 6 months
Marker of kidney inflammation, will be measured before, during, and after treatment
次要结局
- Calcium level(6 months)
研究者
Pringgodigdo Nugroho, MD
Staff of Nephrology and Hypertension Division, Internal Medicine Department
Indonesia University