A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study to Investigate the Safety and Efficacy of Cannabis Oil in Maintenance Hemodialysis Patients With Protein-energy Wasting
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall incidence and prevalence of adverse events
研究概览
简要总结
The study will be performed in two parts: 1) The pharmacokinetic (PK) part and 2) The appetite and nutritional evaluation part.
The PK part of study will be conducted in open label manner on 10 end stage kidney disease (ESKD) patients receiving maintenance hemodialysis (MHD) treatment. For the PK part, a starting dose of cannabis oil -1 drop of 3% cannabis oil once a day [each drop contain 1.2 mg CBD (cannabidiol) and 1.2 mg of ∆9-THC (∆9-tetrahydrocannabinol)], was judged to be safe for a first-in-MHD patient's administration. Escalation to the next higher dose and any dose adjustments of the next dose levels will be based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups. Once the first dosage proved to be safe, there will be a 2 fold increase from the first dose level (2 drops once a day) to the second dose level. The dose levels will be increased by 2-fold from the previous dose level, until basal hunger and prospective consumption ratings assessed by the visual analogue scale (VAS) will increase at least by 10 mm between screening and the study visits (change-from-baseline) . PK parameters will be evaluated after first dosage administration and after dosage increased.
The appetite and nutritional evaluation part of study will be conducted as a 3-month, double-blind, parallel-group, placebo-controlled, single center study. The study population will include 30 ESKD patients receiving MHD treatment with different degrees of protein-energy wasting (PEW) defined as malnutrition-inflammation score (MIS) above 6. A total of 30 subjects will be randomized to treatment with either cannabis oil or matching placebo.
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
- •Male or female, age > 18 years, on MHD hemodialysis treatment at least 3 months
- •Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly
- •Patients with Malnutrition-Inflammation Score (MIS) ≥ 6
- •Informed consent obtained before any trial-related activities
排除标准
- •Previous or current use in cannabis or marijuana
- •Critical illness as defined by the need of respiratory or circulatory support
- •Known or suspected allergy to trial products
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using contraceptive methods
- •Patients with active malignant disease or liver cirrhosis
- •Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
- •Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
- •Patients treated with immunosuppressive agents
- •Patients receiving any of the following medications: Astemizole, Cisapride, Pimozide or Terfenadine
- •Patients suffering from:
- •Acute vasculitis
- •Severe systemic infections
- •Severe Heart failure (NYHA class IV)
- •Severe hepatic disease, defined as ALT or AST levels >3 times upper normal range
- •Mental incapacity, unwillingness or language barrier
- •Any condition judged by the investigator to interfere with trial participation or evaluation of results or to be potentially hazardous to the patient
- •A significant history of alcohol, drug or solvent abuse
- •History of schizophrenia, affective disorder, history of psychiatric hospitalization and diagnosed anxiety disorder
- •The receipt of any investigational drug within 1 month prior to initiating of this study
- •Scheduled renal transplantation (fixed date).
研究组 & 干预措施
Placebo group
1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months
干预措施: Cannabis oil (Drug)
Placebo group
1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months
干预措施: Placebo/ Regular Oil (Drug)
Cannabis oil group
1 drop of 3% cannabis oil once a day during 3 months
干预措施: Cannabis oil (Drug)
Cannabis oil group
1 drop of 3% cannabis oil once a day during 3 months
干预措施: Placebo/ Regular Oil (Drug)
结局指标
主要结局
Overall incidence and prevalence of adverse events
时间窗: For 5 months from the day of randomization
Overall incidence and prevalence of adverse events
Change in appetite assessed by the Visual Analogue Scale (VAS).
时间窗: For 5 months from the day of randomization
VAS, 100 mm in length with words anchored at each end, expressing the most positive (=100) and the most negative rating (=0), will be used to assess specific domains of appetite separately: hunger, satiety, fullness, prospective food consumption. Each domain will be measured by the 0-100mm scale as mentioned above.
次要结局
- Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS).(For 5 months from the day of randomization)
- Change in Health Related Quality of Life assessed by short form 36 (SF-36) quality of life (QoL) scoring system(For 5 months from the day of randomization)
研究者
ilia beberashvili MD
principal investigator
Assaf-Harofeh Medical Center