Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03664141
Status:
WITHDRAWN
Last Update Posted:
2021-07-28
First Post:
2018-07-20
Brief Title:
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study ICON-HP Study
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
TIKUN OLAM has not received approval from the National Committee to conduct research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICON-HP
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 12 mg CBD cannabidiol and 12 mg of 9-THC 9-tetrahydrocannabinol was judged to be safe for a first-in-MHD patients 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
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 12 mg CBD cannabidiol and 12 mg of 9-THC 9-tetrahydrocannabinol was judged to be safe for a first-in-MHD patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None