Condition
Chronic Kidney Disease-Associated Pruritus
Chronic kidney disease-associated pruritus is persistent itching in people with advanced kidney disease, thought to stem from an imbalance in the body's opioid signaling along with inflammation. The evidence is strongest for difelikefalin: in trials, 51% of people had a meaningful drop in itch intensity versus 28% on placebo, lasting up to 64 weeks. Most of that research was in people on hemodialysis, and about half did not reach that level of relief.
Sources: PMID 39712488
- Updated
- How we grade
- 17 studies cited
- Supplements studied
- 0
- Medicines and peptides
- 1
- Graded outcomes
- 3
Prescription medicines and peptides studied, for context
| Grade | Outcome | Effect | Size | Studies | People | Studies list |
|---|---|---|---|---|---|---|
| Itch-Related Quality of Life Pooled analysis: 55.5% achieved ≥15-point Skindex-10 improvement vs 40.5% placebo (P<0.001). 52.1% achieved ≥5-point 5-D Itch improvement vs 42.3% placebo (P=0.01). Sustained benefits to 64 weeks. | Improves (the measure goes down) | Large effect | 17 studies | |||
Studies that measured itch-related quality of life
| ||||||
| Itch Intensity Reduction KALM-1/2 Phase 3: 51% achieved ≥3-point WI-NRS reduction vs 28% placebo (P<0.001). Mean 4.2-point decrease vs 2.5-point placebo. Effects sustained up to 64 weeks. First FDA-approved treatment for CKD-aP. | Improves (the measure goes down) | Large effect | 16 studies | |||
Studies that measured itch intensity reduction
| ||||||
| Sleep Improvement Significant improvement in itch-related sleep disturbance. Reduced nighttime awakening due to pruritus. Benefits consistent across demographic and disease characteristic subgroups. | Improves (the measure goes up) | Large effect | 13 studies | |||
Studies that measured sleep improvement
| ||||||
Key findings
- Itch-Related Quality of LifeImproves (the measure goes down)
- Itch Intensity ReductionImproves (the measure goes down)
- Sleep ImprovementImproves (the measure goes up)
Studies cited
17 studies from PubMed
- Difelikefalin in the treatment of hemodialysis patients with pruritus: a systematic review and meta-analysis.
- Chronic kidney disease-associated pruritus and quality of life with difelikefalin treatment: a post hoc analysis of phase 3 data using the Skindex-10 questionnaire.
- Pathways for Diagnosing and Treating CKD-Associated Pruritus: A Narrative Review.
- Phase 2 Trial of Difelikefalin in Notalgia Paresthetica.
- Difelikefalin: A New κ-Opioid Receptor Agonist for the Treatment of Hemodialysis-Dependent Chronic Kidney Disease-Associated Pruritus
- Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program
- Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies
- A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus
- Clinical Assessment of Tribulus terrestris Extract in the Treatment of Female Sexual Dysfunction
- Efficacy of Tribulus Terrestris for the treatment of premenopausal women with hypoactive sexual desire disorder: a randomized double-blinded, placebo-controlled trial
- Efficacy of Tribulus terrestris for the treatment of hypoactive sexual desire disorder in postmenopausal women: a randomized, double-blinded, placebo-controlled trial
- Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study
- The inhibitory effects of nicotine on physiological sexual arousal in nonsmoking women: results from a randomized, double-blind, placebo-controlled, cross-over trial
- Beneficial effects of Lepidium meyenii (Maca) on psychological symptoms and measures of sexual dysfunction in postmenopausal women are not related to estrogen or androgen content
- Short- and long-term effects of Ginkgo biloba extract on sexual dysfunction in women
- Triple-blind, placebo-controlled trial of Ginkgo biloba in sexual dysfunction due to antidepressant drugs
- Androgens and sexual function: a placebo-controlled, randomized, double-blind study of testosterone vs. dehydroepiandrosterone in men with sexual dysfunction and androgen deficiency