Itching SymptomsNCT07526324
Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease
A study testing Difelikefalin Injection and Normal Saline (0.9% NaCl) in people with Itching Symptoms and CKD 5D, Hemodialysis, run by Chittagong Medical College.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Itching Symptoms, CKD 5D, Hemodialysis
- What is being tested?
- Difelikefalin Injection and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged ≥18 years
- Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis Undergoing hemodialysis for at least 3 months
- Presence of moderate-to-severe pruritus defined as Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥4
- Able and willing to provide written informed consent
Who cannot join
- Known case of Primary skin disesease associated with Itching.
- Known case of liver disease.
- Known case of iron defeciency anaemia ,hematological malignancy.
- Known case of hypothyroidism \& hyperthyroidism.
- Known case of allergic reaction to Opiates .
- Pregnancy.
- Drug abuse, or substance dependence
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Difelikefalin on CKD-Associated Pruritus in Patients on Maintenance Hemodialysis: A Randomized, Placebo-Controlled Trial
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.
Read more
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.
Read the detailed description
Chronic kidney disease-associated pruritus (CKD-aP), alternatively termed uremic pruritus (UP), represents a frequent, distressing, and often incapacitating clinical manifestation among individuals diagnosed with chronic kidney disease (CKD) or end-stage renal disease (ESRD). Characterized by persistent, intense itching-typically generalized but occasionally localized-CKD-aP disproportionately affects patients undergoing hemodialysis, with epidemiological studies reporting a variable prevalence ranging from 22% to 84% in this population. Notably, a substantial subset of these patients, approximately 20-40%, experience moderate-to-severe pruritus, which significantly diminishes their quality of life.
The impact of CKD-aP extends beyond physical discomfort. The condition is associated with chronic sleep disturbances such as insomnia, fatigue, and dermatological complications including excoriations, lichenification, and secondary infections due to repeated scratching. Psychosocially, patients often experience emotional distress, social withdrawal, and stigmatization related to visible skin lesions, which may worsen underlying mental health conditions such as anxiety and depression. Additionally, CKD-aP has been associated with increased mortality in dialysis patients, including higher risks of cardiovascular events and infections, suggesting a link with systemic inflammation and immune dysregulation.
There is a clear need for effective treatment options for CKD-aP. Current off-label therapies include antihistamines, topical corticosteroids, gabapentin, and pregabalin. While some of these treatments may reduce itching, their side effects can limit their use in this population.
The pathogenesis of CKD-aP remains incompletely understood. Proposed mechanisms include metabolic disturbances, immune system dysregulation, and imbalance in the endogenous opioid system, particularly involving peripheral kappa opioid receptors.
Difelikefalin is a peripherally acting, selective kappa opioid receptor agonist that exerts antipruritic effects through activation of receptors on peripheral neurons and immune cells. Its hydrophilic peptide structure limits its ability to cross the blood-brain barrier, thereby reducing central nervous system effects.
Difelikefalin has been approved as the first medication specifically indicated for CKD-aP in patients undergoing dialysis and has demonstrated efficacy in phase 3 clinical trials. It is currently recommended as a first-line treatment for moderate-to-severe CKD-aP in dialysis patients where available.
Despite promising results, some limitations remain. A proportion of patients do not achieve clinically meaningful improvement in itch intensity or quality of life. Clinical trials have demonstrated significant benefits, but response variability persists.
The safety profile of difelikefalin is dose-dependent. Common adverse effects include nausea, vomiting, dizziness, diarrhea, and gait disturbances. A dose of 0.5 μg/kg appears to provide the most favorable balance between efficacy and safety.
Although difelikefalin is a promising treatment option, current evidence remains limited, and additional well-designed randomized controlled trials are needed to confirm its effectiveness.
While most existing studies have been conducted in Western populations, data from low- and middle-income countries such as Bangladesh are limited. The prevalence of CKD in Bangladesh is high, affecting millions of individuals, with a significant number progressing to end-stage renal disease annually.
This study aims to evaluate the superiority of difelikefalin over placebo in reducing pruritus severity among patients undergoing maintenance hemodialysis in a tertiary-level teaching hospital in Bangladesh.
- Conditions
- Itching Symptoms, CKD 5D, Hemodialysis
- Being tested
- Difelikefalin Injection, Normal Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difelikefalin InjectionDrug
ntravenous difelikefalin (κ-opioid receptor agonist) administered at a dose of 0.5 mcg/kg at the end of each hemodialysis session, three times weekly,for a total duration of 6 wks in patients undergoing maintenance hemodialysis with moderate to severe CKD -associated pruritus
Normal Saline (0.9% NaCl)Drug
Intravenous normal saline will be administered at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks, in a volume equivalent to the difelikefalin dose.
| Study group | Role | What they receive |
|---|---|---|
| Difelikefalin Group | Experimental | Difelikefalin (0.5 mcg/kg) will be administered intravenously at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks in patients with CKD-associated pruritus. Receives: Drug: Difelikefalin Injection |
| Placebo (Normal Saline) Group | Placebo comparator | Participants will receive intravenous normal saline at the end of each hemodialysis session, three times per week, for 6 weeks, administered in a volume equivalent to the difelikefalin dose Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Worst Itching Intensity Numerical Rating Scale (WI-NRS) Score at 6 Weeks
The Worst Itching Intensity Numerical Rating Scale (WI-NRS) is an 11-point scale ranging from 0 (no itching) to 10 (worst imaginable itching). The outcome will be reported as the mean change in WI-NRS score from baseline to week 6
Measured: Baseline to Week 6
Secondary outcomes (1)
Change From Baseline in Skindex-10 Score at 6 Weeks
Skindex-10 is a validated questionnaire used to assess quality of life in patients with skin conditions. Scores range from 0 to 60, with higher scores indicating worse quality of life. The outcome will be reported as the mean change from baseline to week 6.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start26 Apr 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Itching SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Standard symptomatic treatment for itching + Intravenous difelikefalin
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.MD.SHARIFUL ISLAM SARKER, Chittagong Medical College
- Investigators
- PROF. DR. MD NURUL HUDA, FCPS,MD, Study chair, Head of the department of nephrology,Chittagong medical college ,Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526324
- Sponsor's protocol ID
- 59.127.1557.013.19.PG.1238
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Difelikefalin on CKD-Associated Pruritus in Patients on Maintenance Hemodialysis: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07526324
- Acronym / sponsor ID
- 59.127.1557.013.19.PG.1238
- Conditions
- Itching Symptoms, CKD 5D, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Study start
- 26 Apr 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic kidney disease-associated pruritus (CKD-aP), alternatively termed uremic pruritus (UP), represents a frequent, distressing, and often incapacitating clinical manifestation among individuals diagnosed with chronic kidney disease (CKD) or end-stage renal disease (ESRD). Characterized by persistent, intense itching-typically generalized but occasionally localized-CKD-aP disproportionately affects patients undergoing hemodialysis, with epidemiological studies reporting a variable prevalence ranging from 22% to 84% in this population. Notably, a substantial subset of these patients, approximately 20-40%, experience moderate-to-severe pruritus, which significantly diminishes their quality of life.
The impact of CKD-aP extends beyond physical discomfort. The condition is associated with chronic sleep disturbances such as insomnia, fatigue, and dermatological complications including excoriations, lichenification, and secondary infections due to repeated scratching. Psychosocially, patients often experience emotional distress, social withdrawal, and stigmatization related to visible skin lesions, which may worsen underlying mental health conditions such as anxiety and depression. Additionally, CKD-aP has been associated with increased mortality in dialysis patients, including higher risks of cardiovascular events and infections, suggesting a link with systemic inflammation and immune dysregulation.
There is a clear need for effective treatment options for CKD-aP. Current off-label therapies include antihistamines, topical corticosteroids, gabapentin, and pregabalin. While some of these treatments may reduce itching, their side effects can limit their use in this population.
The pathogenesis of CKD-aP remains incompletely understood. Proposed mechanisms include metabolic disturbances, immune system dysregulation, and imbalance in the endogenous opioid system, particularly involving peripheral kappa opioid receptors.
Difelikefalin is a peripherally acting, selective kappa opioid receptor agonist that exerts antipruritic effects through activation of receptors on peripheral neurons and immune cells. Its hydrophilic peptide structure limits its ability to cross the blood-brain barrier, thereby reducing central nervous system effects.
Difelikefalin has been approved as the first medication specifically indicated for CKD-aP in patients undergoing dialysis and has demonstrated efficacy in phase 3 clinical trials. It is currently recommended as a first-line treatment for moderate-to-severe CKD-aP in dialysis patients where available.
Despite promising results, some limitations remain. A proportion of patients do not achieve clinically meaningful improvement in itch intensity or quality of life. Clinical trials have demonstrated significant benefits, but response variability persists.
The safety profile of difelikefalin is dose-dependent. Common adverse effects include nausea, vomiting, dizziness, diarrhea, and gait disturbances. A dose of 0.5 μg/kg appears to provide the most favorable balance between efficacy and safety.
Although difelikefalin is a promising treatment option, current evidence remains limited, and additional well-designed randomized controlled trials are needed to confirm its effectiveness.
While most existing studies have been conducted in Western populations, data from low- and middle-income countries such as Bangladesh are limited. The prevalence of CKD in Bangladesh is high, affecting millions of individuals, with a significant number progressing to end-stage renal disease annually.
This study aims to evaluate the superiority of difelikefalin over placebo in reducing pruritus severity among patients undergoing maintenance hemodialysis in a tertiary-level teaching hospital in Bangladesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Standard symptomatic treatment for itching + Intravenous difelikefalin
| Arm | Type | Receives |
|---|---|---|
| Difelikefalin Group | Experimental | Drug: Difelikefalin InjectionDifelikefalin (0.5 mcg/kg) will be administered intravenously at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks in patients with CKD-associated pruritus. |
| Placebo (Normal Saline) Group | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants will receive intravenous normal saline at the end of each hemodialysis session, three times per week, for 6 weeks, administered in a volume equivalent to the difelikefalin dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged ≥18 years
- Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis Undergoing hemodialysis for at least 3 months
- Presence of moderate-to-severe pruritus defined as Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥4
- Able and willing to provide written informed consent
Key exclusion criteria (7 listed)
- Known case of Primary skin disesease associated with Itching.
- Known case of liver disease.
- Known case of iron defeciency anaemia ,hematological malignancy.
- Known case of hypothyroidism \& hyperthyroidism.
- Known case of allergic reaction to Opiates .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difelikefalin Injectionntravenous difelikefalin (κ-opioid receptor agonist) administered at a dose of 0.5 mcg/kg at the end of each hemodialysis session, three times weekly,for a total duration of 6 wks in patients undergoing maintenance hemodialysis with moderate to severe CKD -associated pruritus | Drug | Difelikefalin Group |
| Normal Saline (0.9% NaCl)Intravenous normal saline will be administered at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks, in a volume equivalent to the difelikefalin dose. | Drug | Placebo (Normal Saline) Group |
Primary outcome
Change From Baseline in Worst Itching Intensity Numerical Rating Scale (WI-NRS) Score at 6 Weeks
Time frame: Baseline to Week 6
The Worst Itching Intensity Numerical Rating Scale (WI-NRS) is an 11-point scale ranging from 0 (no itching) to 10 (worst imaginable itching). The outcome will be reported as the mean change in WI-NRS score from baseline to week 6
1 secondary outcome
Change From Baseline in Skindex-10 Score at 6 Weeks
Time frame: Baseline to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PROF. DR. MD NURUL HUDA, FCPS,MD study chair
Head of the department of nephrology,Chittagong medical college ,Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Difelikefalin Injection and Normal Saline (0.9% NaCl) in people with Itching Symptoms and CKD 5D, Hemodialysis, run by Chittagong Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MD SHARIFUL ISLAM SARKER, MBBS (+8801521555223 ext. +8801738647201, sobujshariful@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Worst Itching Intensity Numerical Rating Scale (WI-NRS) Score at 6 Weeks (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.