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

NCT03664141 | Withdrawn Phase 3

• 1 other identifier: Assaf Harofeh MC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein-Energy Malnutrition; Hemodialysis; Appetite Disorders

Keywords

Malnutrition; Hemodialysis; Appetite; Inflammation; Body composition; Cannabis oil

Outcome Measures

Primary Outcomes (2)

• Overall incidence and prevalence of adverse events

  Overall incidence and prevalence of adverse events

  For 5 months from the day of randomization

• Change in appetite assessed by the Visual Analogue Scale (VAS).

  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.

  For 5 months from the day of randomization

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Drug: Cannabis oil; Drug: Placebo/ Regular Oil

Cannabis oil group

EXPERIMENTAL

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

Drug: Cannabis oil; Drug: Placebo/ Regular Oil

Interventions

Cannabis oil DRUG

Treatment with cannabis oil

Cannabis oil group; Placebo group

Placebo/ Regular Oil DRUG

Treatment with placebo (Regular Oil)

Cannabis oil group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Tikun Olam: collaborator

Study Sites (1)

Asaf ha Rofeh, MC

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Protein-Energy Malnutrition; Feeding and Eating Disorders; Malnutrition; Inflammation

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: September 10, 2018
• Study Start: September 15, 2018
• Primary Completion: August 15, 2019
• Study Completion: October 15, 2019
• Last Updated: July 28, 2021

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)