Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

✅ This trial is currently recruiting volunteers

If you think you might be eligible, speak to your GP or specialist about this trial before applying.

Status

Recruiting

Phase

PHASE2

Participants

ALL

Age Range

12 Years – 18 Years

About This Trial

Rationale:

* People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy.
* Difelikefalin is a medicine that can treat the itching related to long term kidney disease.
* Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis, while being safe and tolerable.
* The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group.

The aims of the study are:

Main aim: To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease

Secondary aim: To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease

Study Design At least 18 adolescents, aged 12 to 17 years, who are on haemodialysis and have itching related to long term kidney disease will take part in this study.

All study participants will receive difelikefalin 3 (or up to 4) times weekly for up to 12 weeks. The study duration for a participant is up to 17 to 18 weeks; during this period, participants will visit the clinic 3 times weekly (during their haemodialysis visits).

Who Can Join?

Inclusion Criteria: * Participant must be ≥12 to 4.0 * Over the last 3 months prior to screening, the participant has had at least 1 of the following: 1. At least 2 single-pool Kt/V measurements ≥1.2 on different dialysis days 2. At least 2 urea reduction ratio measurements ≥65% on different dialysis days 3. 1 single-pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis day * Prescription dry body weight ≥20 kg * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Participant and/or legal guardian (as required) is capable of providing the appropriate signed informed consent and where appropriate, assent. Exclusion Criteria: * Known to be non-compliant with HD treatments and deemed unlikely by the Investigator to complete the study * Planned to receive a kidney transplant during the…

View Full Trial Details ↗

⚠ Always speak to your doctor before applying to any clinical trial.