Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP (NCT07380113) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP
50 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen.
The main questions it aims to answer are:
* Does Anruikefen injection improve sleep quality better than oral nalfurafine?
* Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus.
Participants will:
* Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily).
* Continue treatment for 4 weeks, followed by a 1-week safety follow-up.
* Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.
. Male or female individuals aged 18 or above and 75 or above.
. Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers).
. Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP).
. Patients with chronic kidney disease (CKD) presenting with pruritus, with other identifiable causes of pruritus excluded.
. Pruritus occurring on at least 3 days within a 2-week period, with multiple episodes per day, each lasting for several minutes, and having an impact on the patient's daily life.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two drugs — anrikefon and nalfurafine — for itch relief in hemodialysis patients, and it's a Phase 4 study, which means both drugs have already been approved; can you tell me what is already known about the safety and effectiveness of each one, and why comparing them still matters for my care?
2The trial is measuring sleep quality using something called the Pittsburgh Sleep Quality Index — does my current level of sleep disruption from itching make this kind of outcome measurement relevant to my situation, and is sleep quality something you're already tracking for me?
3Since this trial isn't recruiting yet, what options do I have right now for managing my chronic itch related to hemodialysis, and would either of these drugs — anrikefon or nalfurafine — be something you could consider prescribing for me outside of a trial?
4Given that I'm already on hemodialysis, how would participating in a study like this affect my existing dialysis schedule and treatment routine, and is the added commitment realistic for my situation?
5When this trial does open for recruitment, would you consider referring me, or do you think starting with one of these treatments through standard care might be a better first step for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Recurrent pruritus persisting for at least 6 weeks.A diagnosis requires that all three criteria above be met simultaneously.
. The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of ≥ 4 points.
Exclusion criteria
. Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:
. Severe cardiovascular diseases, such as unstable angina, myocardial infarction, severe arrhythmias, World Health Organization (WHO) heart function classification III-IV during screening, poorly controlled hypertension or hypotension despite active treatment, and recurrent asthma.
. A history of cerebrovascular accident (CVA) within the last 6 months.
. Malignant tumors, excluding those that are curable, such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or any other cancer that has been cured (with no evidence of disease recurrence for 5 years).
. It is expected to undergo kidney transplantation and/or parathyroidectomy during the study period.
. The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.
. Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).
. Patients who have used the following drugs within 7 days before screening: