Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664141
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Tikun Olam
Information provided by (Responsible Party):
ilia beberashvili MD, Assaf-Harofeh Medical Center

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Overall incidence and prevalence of adverse events [ Time Frame: For 5 months from the day of randomization ]
    Overall incidence and prevalence of adverse events

  2. 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.


Secondary Outcome Measures :
  1. Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS). [ Time Frame: 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).

  2. 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 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664141


Locations
Layout table for location information
Israel
Asaf ha Rofeh, MC
Zrifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Tikun Olam

Layout table for additonal information
Responsible Party: ilia beberashvili MD, principal investigator, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03664141     History of Changes
Other Study ID Numbers: Assaf Harofeh MC
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ilia beberashvili MD, Assaf-Harofeh Medical Center:
Malnutrition
Hemodialysis
Appetite
Inflammation
Body composition
Cannabis oil
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Protein-Energy Malnutrition
Marijuana Abuse
Feeding and Eating Disorders
Nutrition Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Protein Deficiency
Deficiency Diseases