Changes in Biochemical and Vascular Parameters w/Lanthanum Carbonate & Calcium Acetate Therapy Compared to Dietary Intervention in Pts w/Stage 3 & 4 Chronic Kidney Disease & Abnormal Phosphorus Homeostasis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Designated safety measure; serum calcium
研究概览
简要总结
Objective: To examine the effects of three commonly applied treatments of disordered phosphorus homeostasis on biochemical markers and vascular characteristics in patients with moderate and advanced non-dialysis dependent chronic kidney disease.
详细描述
Approximately 120 qualified patients from our medical center, who have been diagnosed with mild to moderate chronic kidney disease (estimated GFR 15-60 ml/min), will be enrolled. After informed consent, qualified subjects will be randomized into 3 arms in a 1:1:1 ratio: lanthanum carbonate, calcium acetate, and dietary modification. The maximum length of treatment is 12 months. Dose of intervention will be adjusted based on changes in biochemical parameters. Primary end points are changes in serum phosphorus, urine phosphorus, serum parathyroid hormone, coronary artery calcification, aortic pulse velocity and flow mediated vasodilation.
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
- •Male or female CKD patients > 18 years old
- •Patients should be willing and able to provide written informed consent and HIPAA authorization to participate in study
- •Chronic kidney disease Stage 3 or 4 per K-DOQI Guidelines: estimated glomerular filtration rate (eGFR) of 15-60 ml/.min/1.73m2 by using modified MDRD equation.
- •Serum phosphorus >4.6 mg/dl or plasma intact PTH (iPTH) level above 65 pg/ml or tubular reabsorption of phosphorus (TRP) <80%.
- •A negative pregnancy test prior to enrollment in female patients, unless the patient is 2 years postmenopausal, or has had a documented tubal ligation or total hysterectomy.
- •Patients need to be off any phosphorus binders for 4 weeks prior to screening
- •Stable dose of vitamin D products for 4 weeks in patients receiving such agents. Dose changes in patients receiving stable and initiation of vitamin D products in patients previously not treated will not be permitted during study
排除标准
- •Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding
- •Patients currently participating in a clinical trial with another investigational drug or device or who have receiving an investigational drug or device within 30 days of enrollment in this study
- •Major surgery within 2 month prior to enrollment in study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
- •Presence of coronary stents, artificial heart valves or pacemakers, and history of CABG
- •Patients with active infections requiring ongoing treatment
- •Patients who have had a malignancy (except for non-melanoma cancer of the skin) unless the patient has received curative treatment and has been disease free for >2 years
- •Patient who the Investigator determines has a medical status that would preclude the patient's participation in the study
- •Patients on hemodialysis (HD) or peritoneal dialysis (PD)
- •Patients with a functional renal transplant
- •Patients with allergies to study drugs
- •Patients with serum calcium >10.7 mg/dl.
研究组 & 干预措施
Lanthanum Carbonate
Lanthanum Carbonate: initial dose 500 mg TID with meals, titrated at monthly intervals in 500 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis (serum phosphorus, PTH or TRP). Normality for this marker will be defined as serum phosphorus of 2.6-4.6 mg/dl, PTH of 10-65pg/ml and TRP>=80%.
干预措施: Diet counseling (Other)
Calcium Acetate
Calcium Acetate: initial dose 667 mg TID with meals, titrated at monthly intervals in 667 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis. The maximum daily intake of elemental calcium should not exceed 1500 mg in order to comply w/recommendations from K-DOQI [5](this is approximately equal to three 667mg tablets of calcium acetate TID).
干预措施: Diet counseling (Other)
Dietary instructions
Dietary instructions consisting of pamphlets describing foods high in phosphorus and consultation with a renal dietitian if necessary, with the goal of return to normal the level of the abnormal marker of phosphorus homeostasis. Rescue therapy with a phosphorus binder of the treating physician's choice will be allowed in patients who fail to normalize elevated baseline serum phosphorus levels after 3 months following dietary instructions.
干预措施: Phosphorus binder (Drug)
结局指标
主要结局
Designated safety measure; serum calcium
时间窗: 1 year compared to day 0
Changes in calcium, PTH, FGF-23 at 1 year compared to day 0
Designated safety measure: phosphorus
时间窗: 1 year compared to day 0
Changes in serun phosphorus, tubular reabsorption of phosphorus, bone-specific alkaline phosphatase at 1 year compared to day 0
次要结局
- Changes in flow(1 year compared to day 0)
- Other Changes(1 year compared to day 0)