Clinical trial NCT03664141: Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Protein-Energy Malnutrition
Hemodialysis
Appetite Disorders
Keywords: Malnutrition
Hemodialysis
Appetite
Inflammation
Body composition
Cannabis oil
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tikun Olam
First posted: 2018-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Overall incidence and prevalence of adverse events
timeFrame: For 5 months from the day of randomization
measure: Change in appetite assessed by the Visual Analogue Scale (VAS).
timeFrame: For 5 months from the day of randomization
Secondary outcomes:
measure: Change in nutritional status assessed by the Malnutrition-Inflammation Score (MIS).
timeFrame: For 5 months from the day of randomization
measure: Change in Health Related Quality of Life assessed by short form 36 (SF-36) quality of life (QoL) scoring system
timeFrame: For 5 months from the day of randomization
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf ha Rofeh, MC
Study officials:
References: