Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- 24h urine 24hr urine albuminuria
研究概览
简要总结
This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.
详细描述
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
- •Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months
- •Estimated eGFR of 30 to 90 mL/min/1.73 m2
排除标准
- •Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
- •Serum Calcium > 2.45 mmol/L (9.8 mg/dL)
- •Serum Phosphorus > 1.78 mmol/L (5.5 mg/dL)
- •Serum Potassium > 5.5 mmol/L (5 mEq/L)
- •Parathyroid hormone < 20 pg/mL or > 500 pg/mL
- •Hemoglobin A1C > 12%
- •25-OH Vit D > 50 ng/mL
- •Poorly controlled hypertension defined as systolic blood pressure >= 180 mm Hg or diastolic blood pressure >= 110 mm Hg
- •History of kidney stones
- •History of severe disease like chronic liver disease
- •Active malignancy
- •Active granulomatous diseases like turburculosis and sarcoidosis
- •Recent diagnosis of acute renal failure within 3 months of screening visit
- •Likelihood of renal replacement therapy within 1 year
- •History of parathyroidectomy
- •Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
- •Currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. Subjects may also be taking stable dose of estrogen/progestin)
- •History of osteoporosis or other bone disorder requiring calcitriol therapy
- •History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
- •History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
- •Evidence of drug or alcohol abuse
研究组 & 干预措施
Losartan alone
In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.
干预措施: Losartan (Drug)
Losartan and Calcitriol
In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.
干预措施: Calcitriol (Dietary Supplement)
Losartan and Calcitriol
In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.
干预措施: Losartan (Drug)
结局指标
主要结局
24h urine 24hr urine albuminuria
时间窗: 12 month
24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.
次要结局
未报告次要终点