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Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

ABSTRACT: Introduction:There is an unmet medical need for pruritus associated with chronic kidney disease, a distressing complication characterized by generalized and persistent itch affecting 20% to 40% of patients undergoing hemodialysis. Here we report the results of a phase 2 trial evaluating the efficacy and safety of a novel peripherally restricted kappa opioid receptor agonist, difelikefalin, in adult patients undergoing hemodialysis with pruritus. Methods:In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 ?g/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial. The primary endpoint was the change from baseline at week 8 in the weekly mean of the 24-hour Worst Itching Intensity Numerical Rating Scale score. The secondary efficacy endpoint was the change in itch-related quality of life measured by the Skindex-10 questionnaire. Other endpoints included safety, sleep quality, and additional measures including the 5-D itch scale. Results:A significant reduction from baseline in itch intensity scores at week 8 favored all difelikefalin doses combined versus placebo (P = 0.002). Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores (P ? 0.005). Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (?5%). Conclusion:In this trial, difelikefalin effectively reduced itching intensity and improved sleep and itch-related quality of life.

SUBMITTER: Fishbane S

PROVIDER: S-EPMC7210745 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

Fishbane Steven S Mathur Vandana V Germain Michael J MJ Shirazian Shayan S Bhaduri Sarbani S Munera Catherine C Spencer Robert H RH Menzaghi Frédérique F

Kidney international reports 20200128 5

<h4>Introduction</h4>There is an unmet medical need for pruritus associated with chronic kidney disease, a distressing complication characterized by generalized and persistent itch affecting 20% to 40% of patients undergoing hemodialysis. Here we report the results of a phase 2 trial evaluating the efficacy and safety of a novel peripherally restricted kappa opioid receptor agonist, difelikefalin, in adult patients undergoing hemodialysis with pruritus.<h4>Methods</h4>In this study, 174 hemodial ...[more]

PMID: 32405581

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Project description:Background:There is no consensus on intravenous (IV) iron supplement dose, schedule, and serum ferritin target in functional iron deficiency anemia to maintain optimum target levels of iron stores by several guidelines. Objective:To examine the effect of IV iron supplementation to different targets of serum ferritin on erythropoietin dose and inflammatory markers in chronic hemodialysis (HD) patients with functional iron deficiency anemia. Design:A multicenter, randomized, open-label study. Setting:In a developing country, Thailand. Patients:Chronic HD patients with functional iron deficiency anemia. Measurements:Erythropoietin resistance index, high-sensitivity C-reactive protein, and fibroblast growth factor 23. Methods:Two hundred adult chronic HD patients with transferrin saturation less than 30% and serum ferritin of 200 to 400 ng/mL were randomized 1:1 to maintain serum ferritin 200 to 400 ng/mL (low-serum ferritin group, N = 100) or 600 to 700 ng/mL (high-serum ferritin group, N = 100). During a 6-week titration period, participants randomized to the high-serum ferritin group initially received 600 mg IV iron (100 mg every week), while the participants in the low-serum ferritin group did not receive IV iron. During the 6-month follow-up period, the dose of IV iron was adjusted by protocol. Results:The mean dose of IV iron was 108.3 ± 28.2 mg/month in the low-serum ferritin group and 192.3 ± 36.2 mg/month in the high-serum ferritin group. The mean serum ferritin was 367.0 ± 224.9 ng/mL in the low ferritin group and 619.6 ± 265.2 ng/mL in the high ferritin group. The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: -113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: -88.88 ± 234.43 vs -10.48 ± 217.75 unit/week/g/dL; P = .02). Limitations:Short follow-up period. Conclusion:Maintaining a serum ferritin level of 600 to 700 ng/mL by IV iron administration of approximately 200 mg per month as a maintenance protocol can decrease erythropoietin dose requirements in chronic HD patients with functional iron deficiency anemia. Trials registration:The study was registered with the Thai Clinical Trials Registry TCTR20180903003.

Project description:BackgroundHemodialysis is one of the common therapies in patients with end-stage renal disease. Even patients who receive regular treatment suffer from fatigue, which is one of the main factors leading to poor quality of life. This study aimed to determine the effectiveness of exercising on mini-bikes on fatigue in hemodialysis patients.MethodsThis study is a randomized controlled clinical trial. Thirty-seven hemodialysis patients participated in the study. The patients were randomly allocated to either the intervention group (n = 20) or the control group (n = 17). The participants in the intervention group exercised on mini-bikes for 20 min twice a week for 3 months. The patients' fatigue was measured four times during and after the intervention. Multidimensional Fatigue Inventory was used to measure the fatigue level. The total score in the MFI is 4 to 20 for each domain, with the resulting total fatigue score ranging from 20 to 100; thus, the higher the score, the higher the level of fatigue. Data were analyzed by SPSS 18. The repeated measures ANOVA was used to compare the fatigue scores within each group and between the groups at different times.ResultsThe mean score of fatigue in the intervention group at the beginning was 58.80 ± 15.29, which steadily decreased to 58.78 ± 13.54, 58.75 ± 14.73, 54.20 ± 15.16, and 54.23 ± 13.60 for the 3 months of intervention and 1 month post-intervention, respectively. In contrast, in the control group, this score was 62.53 ± 16.32 in the beginning, increasing to 64.03 ± 13.91, 64.22 ± 13.07, 69.53 ± 9.22, for the 3 months of intervention and 70.34 ± 7.69 one-month post-intervention. There were significant differences between the intervention group and the control group in the third month (P = 0.001) and 1 month after the intervention (P < 0.001).ConclusionsThe results showed that rehabilitation through exercising using mini-bikes had a significant impact on preventing further fatigue build-up in hemodialysis patients, making the mini-bike an effective non-pharmaceutical intervention preventing the increase in fatigue experienced by patients undergoing hemodialysis.Trial registrationIranian Registry of Clinical Trials: IRCT20180314039100N1. Registered 10 June 2018.

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Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

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Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

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