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Dr Joshua Rein Offers Insights on Cannabis Use for Chronic Kidney Disease

Conferences | Kidney Week

Several symptoms patients with chronic kidney disease (CKD) experience are approved indications for medical cannabis, said Joshua L Rein, DO, FASN, a nephrologist at Mt. Sinai Hospital in New York City.

Several symptoms patients with chronic kidney disease (CKD) experience are approved indications for medical cannabis, said Joshua L Rein, DO, FASN, a nephrologist at Mt. Sinai Hospital in New York City.

Transcript:

What do we know so far regarding the effects of cannabis on kidney function?

We don’t know that much right now, especially compared to what we know regarding the effects on the brain, lungs and heart, for example. But research on the effects of cannabis on kidney functions is largely limited to a few retrospective cohort studies. Those studies have included smoked recreational cannabis, either in healthy people, or they’ve evaluated any lifetime use among people with kidney disease. There are some differences between recreational cannabis and medicinal cannabis such as the route of administration, the dose, the frequency of use, and all of these can have different effects on long term outcomes. These studies do not demonstrate any association between cannabis use and development or progression of kidney disease. Because of this, though, in order to answer this question, we conducted a study among people at high risk for kidney disease, and we did demonstrate an association between chronic cannabis use and more rapid decline in estimated glomerular filtration rate (eGFR) among people with kidney disease. We presented this research at Kidney Week 2018 and we’re planning to submit the manuscript for publication shortly.

What are the known benefits of this treatment for kidney disease?

Many people use cannabis to treat a variety of ailments. Among people living with kidney disease, it’s estimated that about one quarter to one half of patients experience chronic symptoms such as pain, nausea, anorexia, sleep disturbance, anxiety, and depression. Several of these are approved indications for medical cannabis across the United States in various states. Additionally, anxiety, depression, and insomnia are the most common psychiatric conditions that people self-treat with cannabis. There’s evidence supporting the use of cannabis in patient populations without kidney disease for treating several of these symptoms. Most of the evidence is focused on chronic pain, nausea, and anorexia or loss of appetite. Additionally, many patients living with kidney disease and those on dialysis experience substantial chronic pain. It’s estimated up to 50% of patients can experience chronic pain. Now, over 60% of dialysis patients have received at least one opioid prescription annually, and approximately 20% of dialysis patients take prescription opioids chronically. But we know that the short term and chronic use of opiates are associated with increased morbidity and mortality among people with kidney disease. So cannabis could have a potential therapeutic role in the pain management among these patients. In fact, the National Academies concluded that there’s substantial evidence for the use of cannabis and cannabinoids to treat chronic pain, while several meta-analyses and systematic reviews on cannabis use, including the prescription cannabinoids have given some mixed results for treating chronic pain.

What are some common misconceptions about cannabis use for kidney disease?

One thing that I can think of is that cannabis consumers are no longer the stereotypical lazy stoner. The prevalence of cannabis use in the United States and worldwide has increased considerably over the last decade, but particularly among people over the age of 50, and even more so over the age of 65. This patient population is enriched with chronic illness, including chronic kidney disease. We know that adults with chronic medical conditions are more likely to consume cannabis than healthy individuals. However, we don’t really know the long term health effects of cannabis use on some of these conditions. So it’s that much more important to understand its impact on kidney disease.

Several symptoms patients with chronic kidney disease (CKD) experience are approved indications for medical cannabis, said Joshua L Rein, DO, FASN, a nephrologist at Mt. Sinai Hospital in New York City.

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

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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

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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

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.

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
  • 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
  • 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).
  • 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