Protein-Energy MalnutritionPhase 3ICON-HPNCT03664141
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)
A Phase 3 study testing Cannabis oil in people with Protein-Energy Malnutrition and Hemodialysis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protein-Energy Malnutrition, Hemodialysis, Appetite Disorders
- What is being tested?
- Cannabis oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2018to 15 Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Cannabis oil, Placebo/ Regular Oil
- Keywords
- Malnutrition, Hemodialysis, Appetite, Inflammation, Body composition, Cannabis oil
- Medical subject headings
- Protein-Energy Malnutrition, Feeding and Eating Disorders, Malnutrition, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oilDrug
Treatment with cannabis oil
Placebo/ Regular OilDrug
Treatment with placebo (Regular Oil)
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months Receives: Drug: Cannabis oil; Drug: Placebo/ Regular Oil |
| Cannabis oil group | Experimental | 1 drop of 3% cannabis oil once a day during 3 months Receives: Drug: Cannabis oil; Drug: Placebo/ Regular Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence and prevalence of adverse events
Overall incidence and prevalence of adverse events
Measured: 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.
Measured: For 5 months from the day of randomization
Secondary outcomes (2)
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).
Measured: 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
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.
Measured: For 5 months from the day of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start15 Sep 2018 (estimated)
- Primary completion15 Aug 2019 (estimated)
- Study completion15 Oct 2019 (estimated)
Why it stopped: TIKUN OLAM has not received approval from the National Committee to conduct research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein-Energy MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Tikun Olam
- Responsible party
- Principal investigator, ilia beberashvili MD, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664141
- Sponsor's protocol ID
- Assaf Harofeh MC
- Acronym
- ICON-HP
- Status last verified
- Sep 2018
- First submitted
- 20 Jul 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03664141
- Acronym / sponsor ID
- ICON-HP / Assaf Harofeh MC
- Keywords
- Malnutrition, Hemodialysis, Appetite, Inflammation, Body composition, Cannabis oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: TIKUN OLAM has not received approval from the National Committee to conduct research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Tikun Olam
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 15 Oct 2019 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Cannabis oil, Drug: Placebo/ Regular Oil1 drop of regular oil for food labeled as 3% cannabis oil once a day during 3 months |
| Cannabis oil group | Experimental | Drug: Cannabis oil, Drug: Placebo/ Regular Oil1 drop of 3% cannabis oil once a day during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis oilTreatment with cannabis oil | Drug | Cannabis oil group, Placebo group |
| Placebo/ Regular OilTreatment with placebo (Regular Oil) | Drug | Cannabis oil group, Placebo group |
Primary outcome
Overall incidence and prevalence of adverse events
Time frame: 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).
Time frame: 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.
2 secondary outcomes
Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS).
Time frame: 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
Time frame: For 5 months from the day of randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabis oil in people with Protein-Energy Malnutrition and Hemodialysis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence and prevalence of adverse events (time frame: For 5 months from the day of randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.