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

Primary Purpose

Protein-Energy Malnutrition, Hemodialysis, Appetite Disorders

Status

Withdrawn

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Cannabis oil

Placebo/ Regular Oil

About this trial

This is an interventional treatment trial for Protein-Energy Malnutrition focused on measuring Malnutrition, Hemodialysis, Appetite, Inflammation, Body composition, Cannabis oil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Asaf ha Rofeh, MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Cannabis oil group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall incidence and prevalence of adverse events

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.

Secondary Outcome Measures

Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS).

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

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.

Full Information

NCT ID

NCT03664141

First Posted

July 20, 2018

Last Updated

July 22, 2021

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Tikun Olam

1. Study Identification

Unique Protocol Identification Number

NCT03664141

Brief Title

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

Acronym

ICON-HP

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Withdrawn

Why Stopped

TIKUN OLAM has not received approval from the National Committee to conduct research

Study Start Date

September 15, 2018 (Anticipated)

Primary Completion Date

August 15, 2019 (Anticipated)

Study Completion Date

October 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assaf-Harofeh Medical Center

Collaborators

Tikun Olam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Protein-Energy Malnutrition, Hemodialysis, Appetite Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Cannabis oil group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cannabis oil

Intervention Description

Treatment with cannabis oil

Intervention Type

Drug

Intervention Name(s)

Placebo/ Regular Oil

Intervention Description

Treatment with placebo (Regular Oil)

Primary Outcome Measure Information:

Title

Overall incidence and prevalence of adverse events

Description

Overall incidence and prevalence of adverse events

Time Frame

For 5 months from the day of randomization

Title

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

Description

Time Frame

For 5 months from the day of randomization

Secondary Outcome Measure Information:

Title

Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS).

Description

Time Frame

For 5 months from the day of randomization

Title

Change in Health Related Quality of Life assessed by short form 36 (SF-36) quality of life (QoL) scoring system

Description

Time Frame

For 5 months from the day of randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Asaf ha Rofeh, MC

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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