NCT02469467Unknown1 期
A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis
KDL Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Inorganic phosphorus (Pi) change from baseline to end of treatment
研究概览
简要总结
The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia
详细描述
This study consists of 4 period; 1) screening period: up to 30 days, 2) first washout period: 2 weeks (remove existing phosphate binder effect), 3) treatment period: 8 weeks, and 4) second washout period: 2 weeks (remove VS-505 effect). VS-505 is orally administered with meal for 8 weeks. The starting dose of VS-505 is 1.50 g/day and the dose will be elevated step wise from 1.50 g to 2.25 g, 4.50 g and 6.75 g per day based on the safety assessment and plasma Pi level every 2 weeks during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent given
- •Able to comply with the study procedures and medications
- •On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and hemodiafiltration for ≥12 weeks at screening and during the study period
- •No change in prescribed dose or frequency of any of the following medications within 4 weeks prior to screening
- •Injectable iron agents
- •Oral or injectable active vitamin D3
- •Oral nutritional vitamin D
- •Calcimimetics
- •Calcium supplements
- •Anti-osteoporotic medication including bisphosphonates
- •Calcitonins
- •Must be willing to avoid intentional changes in diet throughout the study
- •Women of child-bearing potential or non-sterile male subjects and those who are sexually active with a non-sterile female partner must agree to use highly effective contraception
- •Plasma Pi level >1.94 mmol/L (6.0 mg/dL) to <3.23 mmol/L (10.0 mg/dL) after 2 weeks washout will qualify patients to enter the treatment period
排除标准
- •Blood purification therapy other than HD (hemodialysis and hemodiafiltration)
- •The plasma Pi level is >2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to screening.
- •Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three tests prior to screening.
- •Pre-emptive or scheduled renal transplant
- •History of hemochromatosis or ferritin ≥1000 mcg/L
- •Oral iron agents including prescribed and over-the-counter drugs at screening.
- •Current clinically significant gastrointestinal (GI) disorder, including GI bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening
- •History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening
- •Hypertension: Defined using pre-dialysis vital of diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg
- •Possible parathyroid intervention including surgical parathyroidectomy and percutaneous ethanol injection therapy during the study period
- •Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin
- •Severe cardiovascular disorders such as recent myocardial infarction; unstable angina; congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6 months), valve stenosis, atrial fibrillation and arrhythmia
- •History of event by cerebrovascular disease or cardiovascular disease within 24 weeks (6 months) prior to screening
- •Active infection or current treatment with antibiotics within 2 weeks prior to screening
- •History of HIV (ELISA and Western blot) test results
- •Known active liver disease with aspartate aminotransferase or alanine aminotransferase levels greater than x3 the upper limit of normal
- •Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior to screening
- •History of allergy of VS-505 and its related components
- •Receipt of any investigational drug within 4 weeks prior to screening
- •Pregnant and breast-feeding women
- •Other patients who in the opinion of the investigators are ineligible for the study
研究组 & 干预措施
VS-505
Experimental
750 mg capsule
干预措施: VS-505 (Dietary Supplement)
结局指标
主要结局
Inorganic phosphorus (Pi) change from baseline to end of treatment
时间窗: 8 weeks
次要结局
- Ca x Pi change from baseline to end of treatment(8 weeks)
- Calcium (Ca) change from baseline to end of treatment(8 weeks)
- intact parathyroid hormone change from baseline to end of treatment(8 weeks)
- Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)(8 weeks)
- Rate of patients whose Pi reaches the goal between 1.13 mmol/L (3.5 mg/dL) and 1.94 mmol/L (6.0 mg/dL)(8 weeks)
研究者
研究点 (1)
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