Prevalence and Severity of Itching in Patients with End-Stage Renal Disease: Treatment with Nalfurafine Hydrochloride

Nakamoto, Hidetomo; Kobayashi, Takehito; Noguchi, Tōru; Kusano, Takeru; Ashitani, Keigo; Imaeda, Hiroyuki; Maezono, Michiko

doi:10.1159/000496637

Cited by 14 publications

(10 citation statements)

References 7 publications

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“…This notwithstanding, another study showed a lack of significant difference in severity of itching and similar prevalence of CI in HD and PD patients (61.8% and 61.5%, respectively). 19 The research also investigated pruritus in a group of patients with stage 4 or 5 CKD without dialysis therapy, where the prevalence of CI was 43.2%. Another cross-sectional study determined the prevalence of CI in a group of 3,780 non-dialysis patients with CKD stages 3-5.…”

Section: Prevalencementioning

confidence: 99%

Chronic Intractable Pruritus in Chronic Kidney Disease Patients: Prevalence, Impact, and Management Challenges — A Narrative Review

Świerczyńska-Mróz¹,

Białynicki‐Birula²,

Szepietowski³

2021

TCRM

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Chronic kidney disease (CKD) is recognized as a leading public health problem and causes numerous health complications. One of the most common and burdensome dermatological symptoms affecting patients undergoing dialysis is CKD-associated pruritus (CKD-aP). This condition not only has a negative impact on sleep, mood, daily activities, and quality of life but also increases the mortality risk of hemodialyzed patients. Despite that, this condition is greatly underestimated in clinical practice. Due to the complex and still not fully understood etiopathogenesis of CKD-aP, the choice of an effective therapy remains a challenge for clinicians. Most common therapeutic algorithms use topical treatment, phototherapy, and various systemic approaches. This review aimed to summarize most recent theories about the pathogenesis, clinical features, and treatment of CKD-aP.

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Section: Prevalencementioning

confidence: 99%

Chronic Intractable Pruritus in Chronic Kidney Disease Patients: Prevalence, Impact, and Management Challenges — A Narrative Review

Świerczyńska-Mróz¹,

Białynicki‐Birula²,

Szepietowski³

2021

TCRM

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“…Several therapeutic approaches have been tried, with varying degrees of success. These include topical approaches, with ointments and phototherapy, massage, essential oils or, more recently, Chinese herbal-bath therapy and acupuncture [3,[13][14][15][16][17][18][19]. A vast array of systemic treatments has also been essayed, including μ-opioid receptor antagonists and κ-agonists, anti-inflammatory and antihistamine medications, and gabapentin, one of the most widely studied drugs, and, possibly also for this reason, the only one associated with a significant improvement in a recent meta-analysis.…”

Section: Pruritus In Ckd-eskdmentioning

confidence: 99%

Charcoal for the management of pruritus and uremic toxins in patients with chronic kidney disease

Cupisti¹,

Piccoli

Gallieni

2020

Current Opinion in Nephrology and Hypertension

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Purpose of the review: Pruritus is an important, prevalent but often neglected symptom in patients with advanced CKD or on dialysis,. This review addresses the use of activated charcoal and its analogs in the treatment of uremic pruritus, which can be a marker of uremic toxicity. Recent findings: When common causes are corrected and dialysis efficiency is optimized, pruritus is mainly ascribed to the retention of middle and protein-bound molecules, of which indoxyl sulfate and p-Cresyl sulfate are the best studied. While hemodialysis and hemodiafiltration are of limited use, activated charcoal and its analogs offer interesting alternatives. Oral preparations are associated with symptom improvement and a better metabolic pattern, probably via a combination of absorption and modification of the intestinal microbiota. Large studies, in well-phenotyped populations, are needed. Hemoperfusion, commonly used in poisoning pathologies, could be an interesting alternative in hemodialysis patients. The treatment has proved promising in some preliminary and small studies; more research is now needed to test its validity. Summary: Oral activated charcoal and hemoperfusion can be proposed to patients with severe refractory pruritus based on positive, albeit scattered evidence. They also contribute to reducing uremic toxins. Research on their implementation associated with well-established treatments is needed to understand whether they can be used as "uremic detoxifiers".

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“…In Japan, nalfurafine hydrochloride (NAL) was launched in 2009; its indication is for 'improvement of pruritus in dialysis patients (only for cases resistant to conventional treatments)' [8,9]. However, the degree of improvement in pruritus in patients receiving NAL has varied considerably [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Anti-pruritic effect of nemolizumab in hemodialysis patients with uremic pruritus: a phase II, randomized, double-blind, placebo-controlled clinical study

et al. 2021

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Background The pathophysiology of uremic pruritus (UP), which is characterized by systemic and intractable itching, remains unclear. As interleukin (IL)-31 may be involved, we conducted a phase II, randomized, controlled study to evaluate nemolizumab (anti-IL-31 receptor A antibody) in Japanese hemodialysis patients with UP. Methods Patients were randomly assigned (1:1:1:1:1) to one of four double-blind groups (receiving a single subcutaneous injection of nemolizumab 0.125, 0.5, or 2.0 mg/kg, or placebo on Day 1) or an open-label reference group (receiving oral nalfurafine hydrochloride 2.5–5 μg once daily for 12 weeks). The primary endpoint was the difference in the absolute change in pruritus visual analog scale (VAS) at Week 4 between placebo and each nemolizumab group. Results The primary efficacy endpoint was not met. The mean change from baseline with all three nemolizumab doses at Week 1, and with 0.5 mg/kg at Week 4, was greater than with placebo. Least square mean differences (95% confidence intervals) in the absolute changes between the placebo arm and each nemolizumab arm were − 2.4 (− 19.7, 14.9) for 0.125 mg/kg, − 8.7 (− 26.6, 9.2) for 0.5 mg/kg, and 0.4 (− 17.0, 17.8) for 2.0 mg/kg. Secondary efficacy parameters including the Shiratori severity score and 5-D itch score failed to show between-group differences. Patients with higher serum IL-31 levels at screening tended to have greater pruritus VAS reductions following nemolizumab treatment. Conclusions In this phase II study in patients with UP, the primary efficacy parameter was not met. Nemolizumab was generally well tolerated with no clinically significant safety concerns. Clinical trial registration JAPIC: JapicCTI-152961, https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-152961.

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Prevalence and Severity of Itching in Patients with End-Stage Renal Disease: Treatment with Nalfurafine Hydrochloride

Cited by 14 publications

References 7 publications

Chronic Intractable Pruritus in Chronic Kidney Disease Patients: Prevalence, Impact, and Management Challenges — A Narrative Review

Chronic Intractable Pruritus in Chronic Kidney Disease Patients: Prevalence, Impact, and Management Challenges — A Narrative Review

Charcoal for the management of pruritus and uremic toxins in patients with chronic kidney disease

Anti-pruritic effect of nemolizumab in hemodialysis patients with uremic pruritus: a phase II, randomized, double-blind, placebo-controlled clinical study

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