Trial reportClinical and experimental nephrology2021
Anti-pruritic effect of nemolizumab in hemodialysis patients with uremic pruritus: a phase II, randomized, double-blind, placebo-controlled clinical study.
Trial report in Clinical and experimental nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Efficacy and safety of different systemic drugs in the treatment of uremic pruritus among hemodialysis patients: a network meta-analysis based on randomized clinical trials.Frontiers in medicine · 2024Pooled it
- Safety and Efficacy of Nemolizumab for Atopic Dermatitis With Pruritus: A Systematic Review and Meta-Regression Analysis of Randomized Controlled Trials.Frontiers in immunology · 2022Pooled it
- Acquired reactive perforating collagenosis treated with nemolizumab.JAAD case reports · 2026Article
- Comparative Analysis of Patient-Reported Outcomes in Chronic Pruritus: Patients with Chronic Liver or Kidney Diseases Exhibit Higher Psychological Distress than Those with Atopic Dermatitis.Dermatology and therapy · 2025Article
- Real-World Evidence Demonstrating Nemolizumab's Rapid Efficacy in Recalcitrant Uremic Pruritus.Cureus · 2025Article
- Patient-Reported Outcome Measures in CKD-Associated Pruritus: A Systematic Review.Kidney medicine · 2025Review
- Effectiveness of Nemolizumab in Improving Dialysis-Associated Pruritus Refractory to Difelikefalin: A Case Report.Cureus · 2025Article
- CKD-Associated Pruritus is Associated with Greater Use of Antidepressants and Anti-pruritus Medications.Advances in therapy · 2025Article
- A Comprehensive Review of Biologics in Phase III and IV Clinical Trials for Atopic Dermatitis.Journal of clinical medicine · 2024Review
- Chronic kidney disease-associated pruritus: what is known and its application in children.Pediatric nephrology (Berlin, Germany) · 2024Review
- Identification and Management of CKD-Associated Pruritus: Current Insights.International journal of nephrology and renovascular disease · 2024Review
- Pathogenesis and Treatment of Pruritus Associated with Chronic Kidney Disease and Cholestasis.International journal of molecular sciences · 2023Review
- Uremic pruritus: pathophysiology, clinical presentation, and treatments.Kidney research and clinical practice · 2023Article
- High Serum IL-31 Concentration Is Associated with Itch among Renal Transplant Recipients.Journal of clinical medicine · 2022Article
- Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study.Dermatology and therapy · 2022Article
- Uremic Pruritus: From Diagnosis to Treatment.Diagnostics (Basel, Switzerland) · 2022Review
- The Serum Level of IL-31 in Patients with Chronic Kidney Disease-Associated Pruritus: What Can We Expect?Toxins · 2022Article
- Chronic Kidney Disease-Associated Pruritus: A Glance at Novel and Lesser-Known Treatments.Cureus · 2022Review
- Review
- Th2 Modulation of Transient Receptor Potential Channels: An Unmet Therapeutic Intervention for Atopic Dermatitis.Frontiers in immunology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsPatients 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.
resultsThe 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.
conclusionsIn 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 registrationJAPIC: JapicCTI-152961, https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-152961 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.