EUCTR2011-006320-20-BG进行中（未招募）不适用
A multicenter, randomized, double-blind, multiple dose, crossover study to evaluate the safety and equivalence of serum phosphate control of a new sevelamer carbonate tablet formulation incomparison with Renvela® in chronic kidney disease patients on hemodialysis - Trial on Safety and Efficacy of Sevelamer Carbonate
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Synthon BV
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] Male and female Caucasian patients aged =18 years. Women of childbearing potential must have a
- •negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control (see paragraph 8.2), or female patients must be either post-menopausal for =1 year or surgically sterilised
- •[2] Stable maintenance hemodialysis regarding frequency (2 or 3 times per week) and dialysis parameters (e.g. average duration, type of dialyzer) for at least 3 months
- •[3] Life expectancy of at least 12 months
- •[4] At screening for patients not receiving previous treatment with phosphate binders or after 2 weeks
- •wash-out for patients who had previous therapy with phosphate binders: Serum phosphorus =1.78 mmol/l (=5.5 mg/dl)
- •[5] Intact parathyroid hormone (iPTH) =87 pmol/l (=800 pg/ml)
- •[6] Patients on stable diet and willing to follow stable diet
- •[7] Patients with ability to follow study instructions and likely to attend and complete all required visits
- •[8] Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[1] Hypersensitivity to sevelamer or to any of the excipients of the study drugs
- •[2] Poorly controlled diabetes mellitus (HbA1c >11%)
- •[3] Poorly controlled hypertension (blood pressure higher than 150/90 mm Hg)
- •[4] Iron overload: serum ferritin >800 ng/ml combined with TSAT >50%
- •[5] Swallowing disorder (dysphagia)
- •[6] Bowel obstruction
- •[7] Gastrointestinal motility disorders including:
- •- untreated or severe gastroparesis,
- •- diverticulosis,
- •- retention of gastric contents, or
- •- abnormal or irregular bowel motion.
- •[8] Active inflammatory bowel disease
- •[9] History of clinically relevant gastrointestinal surgery (excluding minor surgery, such as uncomplicated appendectomy, polypectomy or non-intestinal tract abdominal surgery, such as cholecystectomy)
- •[10] Severe vomiting
- •[11] Severe constipation
- •[12] Concomitant malignancy (except carcinoma in situ not needing other than local therapy and basal cell carcinoma of the skin)
- •[13] Use of:
- •- antacids,
- •- drugs that affect gastrointestinal motility,
- •- ciprofloxacin, (unless this medicinal product is administered at least one hour before or 3 hours after
- •- phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of
- •the study. A calcium supplement is acceptable if the dose remains unchanged between randomization
- •and completion of the study,
- •- levothyroxine,
- •- anti-arrhythmic medication,
- •- anti-seizure medication.
- •[14] Active vasculitis
- •[15] Alcohol /drug dependence or abuse (excluding tobacco abuse)
- •[16] Pregnancy or lactation
- •[17] Women of childbearing potential unable or unwilling to practice adequate contraceptive measures
- •[18] Positive serologic findings for human immunodeficiency virus (HIV) antibodies
- •[19] Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 1 month prior to start of the present study
- •[20] Severe physical or mental concomitant diseases that might hamper the realisation of the trial according to protocol
- •[21] Legal incapacity and/or other circumstances rendering the patient unable to understand the
- •nature, scope and possible consequences of the study
- •[22] Unreliability or lack of cooperation
研究者
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