Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03664141

Collaborator

Tikun Olam (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Protein-Energy Malnutrition Hemodialysis Appetite Disorders	Drug: Cannabis oil Drug: Placebo/ Regular Oil	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2018

Anticipated Primary Completion Date :

Aug 15, 2019

Anticipated Study Completion Date :

Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo group 1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months	Drug: Cannabis oil Treatment with cannabis oil Drug: Placebo/ Regular Oil Treatment with placebo (Regular Oil)
Experimental: Cannabis oil group 1 drop of 3% cannabis oil once a day during 3 months	Drug: Cannabis oil Treatment with cannabis oil Drug: Placebo/ Regular Oil Treatment with placebo (Regular Oil)

Arm

Intervention/Treatment

Placebo Comparator: Placebo group

1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months

Drug: Cannabis oil

Treatment with cannabis oil

Drug: Placebo/ Regular Oil

Treatment with placebo (Regular Oil)

Experimental: Cannabis oil group

1 drop of 3% cannabis oil once a day during 3 months

Drug: Cannabis oil

Treatment with cannabis oil

Drug: Placebo/ Regular Oil

Treatment with placebo (Regular Oil)

Outcome Measures

Primary Outcome Measures

Overall incidence and prevalence of adverse events [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). [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.

Secondary Outcome Measures

Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS). [For 5 months from the day of randomization]
MIS consists of four sections (nutritional history, physical examination, body mass index [BMI], and laboratory values) and 10 components. Each MIS component has four levels of severity from 0 (normal) to 3 (very severe). The sum of all 10 components results in an overall score ranging from 0 (normal) to 30 (severely malnourished).
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]
SF-36 consists of 36 questions, 35 of which are compressed into eight multi-item scales: (1) physical functioning; (2) role-physical (3) bodily pain ; (4) general health; (5) vitality ; (6) social functioning (7) role-emotional and (8) mental health. In the SF36 scoring system, the scales are assessed quantitatively, each on the basis of answers to two to ten multiple choice questions, and a score between 0 and 100 is then calculated on the basis of well-defined guidelines, with a higher score indicating a better state of health.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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).