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. Read our disclaimer for details.|
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.
|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
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
Chronic Renal Failure and CBD
Updated on March 2, 2020. Medical content reviewed by Dr. Joseph Rosado, MD, M.B.A, Chief Medical Officer
Cannabidiol (CBD) acts as a natural alternative or supplement to typical treatments for kidney disease. Learn how CBD works with your body to provide relief.
About Chronic Renal Failure
Also known as CRF or chronic kidney disease, chronic renal failure happens when your kidney starts to lose function. We need our kidneys to filter excess waste and get rid of it through urine. When the kidney stops working as intended, this waste builds up in your system.
The symptoms of CRF develop at the same pace as the kidney damage’s progress. You can experience fluid buildup in your ankles, feet, heart or lungs. CRF can also cause eating issues such as nausea and appetite loss. Some patients feel tired all the time or have difficulty thinking. A diseased kidney can impact all parts of the body because of the lack of the organ’s critical functions.
Chronic kidney disease can also cause pain. In the early stages of the disorder, you may get muscle cramps that feel painful. During the late stages, you can have pain in your back or abdomen. Natural pain relievers like CBD can relieve these symptoms without causing further damage to your kidney.
The Endocannabinoid System and CRF
Cannabinoids such as CBD heal our bodies by working with our natural systems. We all have an endocannabinoid system that creates and uses these compounds. When a cannabinoid activates one of the system’s receptors, it regulates bodily functions like sensation and mood. The body can also produce endocannabinoids as a response to certain kinds of stimuli or damage.
When CRF causes pain, the body releases the endocannabinoid anandamide as a defense mechanism. Damaged and inflamed tissue creates extra cannabinoids to regulate your pain response. Anandamide also has a role to play in mood, digestion and other functions.
Relieving Chronic Kidney Disease Pain With CBD
Taking CBD lets you tap into your body’s innate healing powers to make your CRF symptoms more comfortable. It relieves pain so you can focus on other aspects of your recovery.
CBD has a unique interaction with your endocannabinoid system. Most cannabinoids, including tetrahydrocannabinol (THC), attach to your cannabinoid receptors. The receptors then use the compound to send signals to your body. When you use CBD, it enhances the function of your endocannabinoid system. It blocks FAAH, a fatty acid that breaks down anandamide to help you keep more anandamide in your body.
As a result, your kidney tissue can create more anandamide when it sends pain signals. The anandamide binds to your CB1 receptors to control your pain response. You can find these CB1 receptors throughout your body, including organ tissue. Some researchers think CB1 receptors could even act as a necessary part of your system’s pain management.
Taking CBD can also manipulate your endocannabinoid system to relieve additional symptoms of CRF. It impacts your sleep-wake cycle, so it helps you get to sleep at night. When CRF causes elevated blood pressure, CBD lowers it to lessen the stress on your heart.
Anandamide is just one of many cannabinoids found in marijuana and your body. Combining CBD treatment with cannabinoids such as THC can improve your symptom relief. The entourage effect happens when you take multiple kinds of cannabinoids. This phenomenon lets cannabinoids complement one another’s benefits for an enhanced effect.
Using CBD as a Non-Toxic Alternative to Painkillers
Patients with all sorts of conditions want to reduce their reliance on painkillers, including patients with kidney disease. Lowering or eliminating your painkiller doses will protect your kidneys from further harm. Some CRF patients can’t use painkillers at all, making it crucial to find an alternative.
CBD helps your body manage pain without the toxic effects of painkillers. Anandamide and other compounds your endocannabinoid system produces cause no harm to your kidneys. You can feel relief while feeling confident your treatment won’t make your condition worse.
How to Find the Right CBD Medicine
Your selection of CBD medication depends on your local and state laws. Medicine like CBD oil has a murky status in federal law, but you can often buy it without repercussions. You may have access to high-CBD, low-THC products through your medical marijuana program. These items contain THC, but the high amount of CBD reduces its effects on the mind.
We recommend consulting a marijuana-trained doctor for assistance with choosing a medicine. They can even help patients who prefer formulas with CBD only. Your physician will work with you to find a product type and formulation that relieves your CRF symptoms.
More Knowledge From the Experts at MarijuanaDoctors.com
At MarijuanaDoctors.com, we have one of the biggest information sources on the Internet for patients like you. Visit our list of ailments to learn more about cannabis medicine’s healing properties.
Learn More About Chronic Renal Failure
Learn more about Chronic Renal Failure and what makes medical marijuana an effective treatment for Chronic Renal Failure’s symptoms.
If you are suffering from Chronic Renal Failure, learn more about your marijuana-related treatment options. Find out how CBD can be used as part of your treatment.