Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14
研究概览
简要总结
The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.
详细描述
The Study Drug:
Tolvaptan is designed to help raise salt levels in your blood by removing extra body water as urine.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will take tolvaptan and receive standard of care
- If you are in Group 2, you will take a placebo and receive the standard of care for patients with hyponatremia. A placebo is a tablet that looks like the study drug but has no active ingredients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Euvolemic or hypervolemic (patients with heart or liver failure) with cancer admitted to MD Anderson Cancer Center for any reasons with serum sodium between 125 and 130 mEq/L (both inclusive)
- •Patients must be greater than or equal to 18 years of age
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 at baseline.
- •Women of childbearing potential must use a medically accepted method of contraception and to continue use of this method for the duration of the study and for 30 days after study participation. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. Men must practice abstinence or use a barrier method of birth control, and must agree to continue use for the duration of the study and for 30 days after study participation.
- •Subjects must be able to comply with scheduled visits and follow-ups.
- •Informed consent must be signed
排除标准
- •History of hypersensitivity to tolvaptan
- •Patients admitted to the critical care unit.
- •Patients with renal failure(creatinine clearance less than 25 ml/min)
- •Patients with a life expectancy less than 3 months
- •Patients with volume depletion, BP < 100/60 or urinary sodium <20 meq/L.
- •Patients who are not able to swallow or cannot take medication through feeding tubes
- •Patients with diuretic-induced hyponatremia.
- •Patients with spurious hyponatremia
- •Patients with hyponatremia related to psychogenic polydypsia, head trauma, post operative conditions, uncontrolled hypothyroidism or cortisol insufficiency or any hyponatremia associated with the use of medication that can be safely withdrawn.
- •The use of alcohol while participating in the study
- •Currently taking demeclocycline, lithium, benzazepine derivatives, ketoconazole, grapefruit, grapefruit juice and receiving strong CYP3A inhibitors such as clarithromycin, fluconazole, voriconazole, posaconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin.
研究组 & 干预措施
Tolvaptan Group
Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days.
干预措施: Tolvaptan (Drug)
Placebo Group
Placebo Group: Placebo by mouth once a day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14
时间窗: 14 days
Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.
次要结局
- Length of Stay in Hospital(From administration of treatment to time of discharge)