NCT01057108已完成1 期
A Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of FOSTRAP Chewing Gum in Patients With Chronic Kidney Disease and Hyperphosphatemia.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change in serum phosphorus from baseline to Day 29
研究概览
简要总结
The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.
详细描述
A double-blind, randomized, placebo, controlled trial with an open label extension for those subjects with end stage renal disease (ESRD).
Patients with ESRD will be randomized to receive either FOSTRAP™ 20 mg BID, FOSTRAP™ 40 mg BID or matching placebo 2x/day. All subjects will participate in a 4 week chewing period followed by a 4 week follow up period. All subjects will then enter an open label 2 week extension phase in which they will receive FOSTRAP™ 20 mg TID.
Patients with chronic kidney disease (CKD) not on dialysis will receive either FOSTRAP™ 20 mg 3x/day or placebo TID for 4 weeks followed by a 4 week follow up period.
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
- •Men or women > 18 years of age;
- •The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
- •The subject will, in the opinion of the investigator, be compliant with prescribed therapy;
- •Subject must be able to communicate and be able to understand and comply with the requirements of the study;
- •For subjects with CKD not on dialysis- kidney function at any stage that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
- •For subjects with CKD not on dialysis- a screening serum phosphorus value greater than or equal to 4.5 mg/dL;
- •For subjects with ESRD - a screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL and one of the two conditions: A mean historical value of the most recent 2 phosphorus measurements ≥ 4.6 and less than or equal to 9.0 mg/dL at the time of written informed consent or A second screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL performed not less than 7 days from the date of the previous screening;
- •In the opinion of the investigator, subjects with ESRD must be prescribed a stable dialysis regimen (3x/week) for ≥ 4 weeks prior to baseline and must have a stable dialysis access;
- •Subjects with ESRD must have an historical URR ≥ 65% for at least 4 weeks prior to baseline;
- •All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to baseline:
- •Phosphate binding products including prescribed and over-the counter
- •Oral or injectable active vitamin D
- •Oral nutritional vitamin D
- •Calcimimetics
- •Calcium supplements
- •Anti-osteoporotic medication (e.g. bisphosphonates)
- •Subject must be prescribed a diet appropriate for patients with their stage of kidney disease, and must be willing to avoid intentional changes in diet; and
- •Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min.
- •Exclusion criteria:
- •Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to baseline;
- •Known sensitivity to chitin or allergy to shellfish;
- •Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
- •Clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
- •Inpatient hospitalization within 14 days prior to baseline with the exception of hospitalizations related to vascular access procedures;
- •Planned surgical intervention for secondary hyperparathyroidism;
- •In the opinion of the investigator, inability to chew gum for 60 minutes;
- •Planned relocation to another area within the next 4 months;
- •Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
- •Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
- •Unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
- •Known active liver disease with AST or ALT levels greater than 3X the upper limit of normal; and
- •Subject has had a major cardiovascular event within 90 days of screening. The investigator should be guided by evidence of any of the following;
- •Acute myocardial infarction
- •Acute cerebral vascular event
- •Vascular surgical intervention
- •Coronary Revascularization
- •Decompensated congestive heart failure
排除标准
- 未提供
结局指标
主要结局
Change in serum phosphorus from baseline to Day 29
时间窗: Day 1 and Day 29
次要结局
- Change in salivary phosphorus from baseline to Day 29(Day and Day 29)
- Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 0.5 mg/dL(Day 1 and Day 29)
- Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 1.5 mg/dL(Day 1 and Day 29)
- Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD(Day 57 and Day 71)
- For subjects with ESRD absolute and relative difference between serum phosphorus (baseline to Day 29)- (Day 57 to day 71)(Day 29, Day 57, Day 71)
- Change in salivary phosphorus from Day 57 to Day 71(Day 57 and Day 71)
研究者
研究点 (2)
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