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NCT07526324
Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
NA trial testing Difelikefalin Injection in Itching Symptoms in 106 participants. Not yet recruiting.
30 January 2027
Quick facts
| Lead sponsor | Chittagong Medical College |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 106 |
| Start date | 26 April 2026 |
| Primary completion | 30 January 2027 |
| Estimated completion | 30 January 2027 |
Drugs / interventions tested
- Difelikefalin Injection — full drug profile →
- Normal Saline (0.9% NaCl) — full drug profile →
Conditions studied
- Itching Symptoms — all drugs for Itching Symptoms →
- CKD 5D, Hemodialysis — all drugs for CKD 5D, Hemodialysis →
Sponsor
Chittagong Medical College
Who can join
18 and older, any sex, with Itching Symptoms or CKD 5D, Hemodialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized, placebo-controlled, double-blind trial will be conducted in the Department of Nephrology at Chittagong Medical College Hospital, Chattogram, Bangladesh, over a period of one and a half years. A total of 102 patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis will be enrolled in the study. Patients with moderate-to-severe pruritus, defined as a Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥ 4, will be included. Eligible participants will be randomly assigned in a 1:1 ratio to receive either difelikefalin (0.5 mcg/kg) or placebo administered intravenously after each hemodialysis session for 6 weeks. The primary outcome measure will be the change in WI-NRS score from baseline to week 6. Secondary outcomes will include changes in quality of life assessed using the Skindex-10 scale. Adverse events and safety parameters will also be monitored throughout the study period. The primary analysis will be conducted using the intention-to-treat principle. A per-protocol analysis may also be performed as a secondary analysis. Statistical analysis will be carried out using SPSS version 27.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07526324
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Related trials
Other trials of Difelikefalin Injection
Trials testing the same drug.
- NCT05885763 — Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis · Phase 1 · completed
- NCT05885737 — Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus · Phase 3 · completed
Other Chittagong Medical College trials
Trials by the same sponsor.
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- NCT06847139 — Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07526324 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chittagong Medical College
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07526324.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing