A Phase 4 interventional study of Nalfurafine Hydrochloride and plasebo in Chronic Kidney Disease Associated Pruritus and End Stage Renal Disease on Dialysis, sponsored by Indonesia University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Indonesia University · Phase 4, Interventional, and Treatment
This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.
Pruritus (severe itching) is a common and distressing symptom in patients with end-stage renal disease receiving hemodialysis, significantly impairing their quality of life. Nalfurafine is a selective kappa-opioid receptor agonist designed to reduce itching.
The main objective of this clinical trial is to evaluate whether nalfurafine effectively reduces itch intensity and improves symptom control compared to control, while monitoring for any adverse effects.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 36 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm receive Nalfurafine therapy alongside standard hemodialysis care.
Drug: Nalfurafine Hydrochloride
Patients in this arm receive matching placebo (or standard care) alongside standard hemodialysis care.
Drug: plasebo
administered orally
administered orally
Change from baseline in Visual Analog Scale (VAS) score for pruritus
Pruritus intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10 (or 0 to 100 mm), where 0 represents no itch and 10 (or 100) represents the worst imaginable itch. Lower scores indicate reduction in itch severity.
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared in order to protect participant confidentiality and privacy in accordance with local ethical guidelines and patient consent.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TRK 820