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Peptide

Difelikefalin

Injectable peptide for moderate to severe itching associated with chronic kidney disease in patients on hemodialysis.
Regulatory status
Approved (FDA / EMA)
Family
Peripheral kappa opioid receptor agonist
Scientific evidence
High
Number of findings
1
Where it acts
Heart and blood · Skin and aging
Also known as
difelikefalin, Korsuva, Kapruvia, CR845

Regulatory status

FDA (U.S.): Approved (2021, Korsuva) for moderate-to-severe pruritus associated with chronic kidney disease in adults on hemodialysis.

EMA (EU): Approved (2022, Kapruvia) for moderate-to-severe pruritus associated with chronic kidney disease in adults on hemodialysis.

Dose

0.5 micrograms/kg of dry weight intravenously at the end of each hemodialysis session, three times a week (FDA label 2021 / EMA 2022).

Safety

Diarrhea, dizziness, drowsiness, nausea, vomiting, and gait disturbances (falls). Caution with sedative drugs. Only under the control of the nephrology team.

Interactions

More drowsiness and dizziness with other central nervous system depressants (opioids, benzodiazepines, sedating antihistamines, gabapentinoids).

Effect by goal · level of evidence

Itching in hemodialysis patients (KALM-1)

reduces High RCT (AA) in people
49% vs 28% responders

378 hemodialysis patients, 12 weeks. 49.1% with difelikefalin vs 27.9% with placebo improved by at least 3 points on the itch scale, with better itch-related quality of life. Diarrhea, dizziness, and vomiting were more frequent.

View the study (RCT) →

In depth

Where it acts

Heart and blood, Skin and aging

How it works

It activates kappa opioid receptors on peripheral nerves and immune cells, which reduces the itch signal and inflammation. It barely enters the brain, so it carries little risk of central opioid effects.

What the evidence says

In people

  • Itch in hemodialysis patients (KALM-1). 378 hemodialysis patients, 12 weeks. A drop of at least 3 points on the itch scale occurred in 49.1% with difelikefalin versus 27.9% with placebo, with better itch-related quality of life. Diarrhea, dizziness and vomiting were more frequent. PubMed 31702883

References

  1. PubMed 31702883

Information, not medical advice. Prescription or unapproved peptides should only be used under medical supervision.

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