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Uremic Pruritus clinical trials

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NCT ID: NCT06159686 Completed - Uremic Pruritus Clinical Trials

The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus

Start date: September 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms. This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.

NCT ID: NCT05885737 Recruiting - Uremic Pruritus Clinical Trials

Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This a multicentre study that consists of a 12-week double-blind period, and an optional 14-week open-label extension period and a 1-week follow-up period.

NCT ID: NCT05575193 Completed - Hemodialysis Clinical Trials

Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group.

NCT ID: NCT05525234 Not yet recruiting - Uremic Pruritus Clinical Trials

A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

Start date: September 15, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of thalidomide in the treatment of refractory uremic pruritus in maintenance hemodialysis patients.

NCT ID: NCT05466045 Not yet recruiting - Uremic Pruritus Clinical Trials

Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Background and Purpose: Itching is a common complication of hemodialysis patients, which can cause skin damage and affect the patient's comfort. Studies have shown that olive oil is feasible and effective for pain relief, cancer treatment, stroke and cardiovascular disease, as well as wound healing and skin care because it is readily available, natural, and has merely no side effects, and there is no research application on the skin itchiness in hemodialysis patients. The purpose of this study was to investigate the effect of applying extra virgin olive oil to improve skin itching, sleep quality and changes in heart rate variability in hemodialysis patients. Research method: This study is designed as a randomized controlled trial (RCT), which is divided into two groups, the experimental group and the control group. Before the interventional measures, a questionnaire pre-test and HRV test are given first, and the interventional measures are given. During the period, in addition to routine care, both groups of patients used a brown roller ball glass bottle containing extra virgin olive oil or normal saline on the itchy skin every 12 hours gently and evenly smeared with fingers , for 28 days, and on the 14th day and 28 days.After intervention, the post-questionnaire test and HRV test were carried out. The research tools include: 5-D 5-D itch scale, Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index (PSQI) and Heart Rate Variability (HRV) detector.The data collection results were archived with Statistical Package for the Social Sciences (SPSS) statistical software, and the data were processed and analyzed by descriptive statistics, chi-square test, generalized estimating equation (GEE) and independent sample t test. Expected results: Result showed using extra virgin olive oil can improvement of skin itchiness and sleep quality in hemodialysis patients, and also cost effectiveness of lotions , reduction of drugs burden on kidneys and improvement of patients' quality of life.

NCT ID: NCT05031546 Approved for marketing - Uremic Pruritus Clinical Trials

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Start date: n/a
Phase:
Study type: Expanded Access

This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.

NCT ID: NCT04728984 Recruiting - Uremic Pruritus Clinical Trials

A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet

Start date: September 7, 2020
Phase: Phase 3
Study type: Interventional

This is a multisite study to evaluate the efficacy, safety and plasma concentration of Nalfurafine Hydrochloride orally disintegrating tablet in the treatment of refractory pruritus in maintenance hemodialysis patients, and to bridge the efficacy data from Japan

NCT ID: NCT04711603 Completed - Uremic Pruritus Clinical Trials

A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Start date: January 16, 2021
Phase: Phase 3
Study type: Interventional

Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.

NCT ID: NCT04650750 Not yet recruiting - Uremic Pruritus Clinical Trials

The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Start date: December 1, 2020
Phase: Early Phase 1
Study type: Interventional

The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined. In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.

NCT ID: NCT04639674 Completed - Uremic Pruritus Clinical Trials

AST-120 in Hemodialysis Patients With Uremic Pruritus

AST-120
Start date: July 2, 2020
Phase: Phase 4
Study type: Interventional

The prevalence of cutaneous pruritus among hemodialysis patients is about 50% to 80%. There is only a handful of studies on the itchy skin of hemodialysis patients and the findings are to be validated. Effective drugs to treat cutaneous pruritus are not available yet. Hence, the purpose of the study is to eliminate the uremic toxins from the intestinal tract using AST-120 as a treatment measure to improve the symptom of the hemodialysis patients' cutaneous pruritus and discuss and assess its effectiveness. For this, the investigators will recruit 150 patients to validate the application potential of the AST-120 in the cutaneous pruritus brought about by uremia.