Pos-676 Exploratory Study To Assess The Safety of Sublingual Oil Based Medical Cannabis Bol-Dp-O-04 in Dialysis Patients Who Have Chronic Pain

ISN WCN 2021, MONTREAL, CANADA
death, CPR, other life-prolonging treatments, major operations, IV to sepsis (WPE). Of those patients who completed at least one treat-
fluids, IV antibiotics, other IV drugs and blood transfusions. Meta- ment period, 7 patients were in the WPE arm, 5 in API and 9 in the
data including who completed the form, document review period placebo arm. The mean patient age was 64.5 (+12.6) years, 92.8%
and completeness of form were recorded. Data were analysed were males. Most common adverse events were sleepiness and dizzi-
descriptively using SPSS. ness, reported in 2 patients in API arm, 4 patients in the WPE and 2
Results: Median age of the 100 people was 74 years (range 66-79.75), patients in placebo arm. Sleepiness improved in all cases after dose
35% were female. Most people (96%) self-identified kidney problems reduction or patient adaptation. Blood pressure was decreased in 1
and 18% of the cohort further self-reported cancer, 34% diabetes patient in the WPE arm and 1 patient in the placebo arm, and
and 47% heart problems. 19% of the cohort had an AHD, 49% an elevated in 2 patients in WPE arm and 3 patients in the placebo arm.
EPOA and only 1% a Tribunal Appointed Guardian, results of Two patients had mild abdominal pain on API and 1 patient had a
which were not mutually exclusive. 90% were deemed to have the headache on WPE. Most adverse effects were of mild to moderate
capacity for decision making as measured by Form A completion severity and resolved spontaneously. Serious adverse events (SAE)
rates. 36% of the cohort recorded a preference to die at home, 25% included one episode of accidental overdose from WPE leading to
in hospital, 6% in a nursing home, and 23% had no recorded hallucinations and tachycardia, one patient was diagnosed with mitral
preference. The majority did not want CPR (75%) and or other life- valve regurgitation and atrial fibrillation during washout period
prolonging measures (76%). 34% said they would have an operation following WPE treatment, one patient with asymptomatic atrial flutter
if it became necessary, 76% said they would have IV fluids, 75% diagnosed during washout period, 5 weeks after API completion, and
would have IV antibiotics, 75% would have other IV drugs and one patient diagnosed with soft tissue sarcoma during WPE use.
70% would have a blood transfusion. Regarding Form B SOC forms, Excluding drug overdose, the majority of SAEs were considered non-
20% were completed by a son or daughter, 40% were completed by related to study drug. No blood tests abnormalities including changes
siblings, and 40% were completed by partners. 95% of forms were in liver enzymes were observed in response to cannabis treatment
completed in full. (Figure 1).
Conclusions: Our study found that most people referred to our KSC
did not want resuscitation or invasive life-prolonging treatment at
end-of-life. Patients appeared to discriminate between these in-
terventions and interventions that might deliver better quality, as
opposed to quantity of life. The majority of people who recorded a
preference of place at end of life indicated that they wished to stay
at home.
No conflict of interest
POS-676
EXPLORATORY STUDY TO ASSESS
THE SAFETY OF SUBLINGUAL OIL
BASED MEDICAL CANNABIS BOL-DP-O-04
IN DIALYSIS PATIENTS WHO HAVE CHRONIC
PAIN
KLIUK-BEN BASSAT, O*1, Brill, S2, Vaisman, N3,4, Schechter, M5,
Ashtamker, N4, Hirshberg, B4, Mosenzon, O4,6
1
Tel-Aviv Sourasky medical center, Nephrology, Tel-Aviv, Israel, 2Tel Aviv Conclusions: Overall, sublingual oil based medical cannabis
Sourasky Medical Center, Institute of Pain Medicine- Department of appeared to be safe and well tolerated in hemodialysis patients as
Anesthesiology and Critical Care Medicine, Tel Aviv, Israel, 3Tel Aviv long as treatment is performed under close medical supervision
Sourasky Medical Center, Gastroenterology, Tel Aviv, Israel, 4BOL, BOL and carful titration. This data supports further clinical
pharma, Tel Aviv, Israel, 5Hadassah Hebrew University Medical Center,
Diabetes unit, Jerusalem, Israel, 6Hadassah Hebrew University Medical
development.
Center, Department of Endocrinology and Metabolism- Diabetes unit, Conflict of Interest: Natalia Ashtamker and Boaz Hirshberg work in
Jerusalem, Israel BOL pharma. Silviu Brill, Nachum Vaisman and Ofri Mosenzon are in
BOL pharma's advisory board.Orit Kliuk-Ben Bassat and Meir
Introduction: While chronic pain resulting in significant impact to the
Schechter declare no conflict of interest.
quality of life of dialysis patients is common, there are few analgesic
options available. We hypothesized that medical cannabis may offer a
safe and effective option for pain control. The aim of this exploratory POS-677
study was to evaluate the safety of sublingual oil based medical
cannabis in dialysis patients. THE ASSESSMENT OF COMORBIDITY AND
Methods: In a prospective randomized double-blind cross-over design, MORTALITY IN GERIATRIC PATIENTS WITH
hemodialysis patients with chronic pain were assigned to one of 3 CKD 3B-5 STAGES
arms: BOL-DP-o-04-WPE Whole-plant extract (WPE), BOL-DP-o-04
cannabinoid extraction (API) arm or placebo. WPE and API contained Maksudova, A*1
1
trans-delta9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in 1:6 Kazan State Medical University, Hospital Therapy, Kazan, Russia
ratio (1:6, THC:CBD). Each arm was comprised of 2 week titration Introduction: The prevalence of chronic kidney disease (CKD) increases
period, followed by 6 weeks of active stable-dose treatment. Each oil dramatically with age–almost 50% of people over the age of 70 have
drop contained 0.034 ml; three drops (0.1ml) contained 2.5mg THC and stage 3-5 CKD. Among patients aged 65 and older, the risk of devel-
15mg CBD. Maximal dose allowed was 6 drops 3 times per day. Side oping end-stage chronic renal failure (ESRD) exceeds the risk of death
effects and laboratory data were documented. After completion of the only in those with eGFR <15ml/min/1, 73m2. Geriatric patients with
first phase, patients entered a 2-weeks wash out period, followed by a pre-dialysis stages of CKD are recommended to assess the risk of ab-
cross-over to a different arm. The primary endpoint was treatment solute probability of death of the patient both in the case of starting
safety. dialysis and without it. Preparation for renal replacement therapy
Results: Of 18 patients enrolled, 3 patients did not start study drug (2 (RRT) may take longer due to comorbidity and frailty. Comorbidity and
withdrew consent, one died during screening period), 3 patients mortality rates in this population of patients have not been evaluated in
stopped treatment before completion of the first titration period due Russia.
to adverse events (sleepiness - WPE, hypotension – API, and con- Methods: Materials and methods: a study of 151 geriatric patients with
stipation – placebo) and one patient died during titration period due stage 3B-5 CKD, average age 77 8.6. All patients were evaluated for
Kidney International Reports (2021) 6, S1–S362 295

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ISN WCN 2021, MONTREAL, CANADA

Kidney International Reports (2021) 6, S1–S362 295

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