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Clinical Trials/EUCTR2017-004098-15-EE
EUCTR2017-004098-15-EE
Active, not recruiting
Phase 1

A Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Assessthe Efficacy and Safety of Orally Administered DS107 in a once daily doseof 2g in Haemodialysis Patients with Moderate to Severe Uremic Pruritus

DS Biopharma0 sites110 target enrollmentJune 5, 2018
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ConditionsModerate to Severe Uremic PruritusMedDRA version: 20.0Level: LLTClassification code 10060884Term: Uremic pruritusSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Moderate to Severe Uremic Pruritus
Sponsor
DS Biopharma
Enrollment
110
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 5, 2018
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female patients who are aged 18 years and older on the day of signing the informed consent form (ICF).
  • •2\. Patients who are on stable haemodialysis 3 times a week for at least 3 months prior to screening with a urine production of less than 300 ml per day.
  • •3\. Patients with continued (uncontrolled) pruritus despite standard of care in the institution.
  • •4\. Patients with moderate to severe pruritus, as determined by qualifying mean worst NRS score in a day of \=5 (on 11 point NRS) at the screening visit.
  • •5\. Female patients and male patients with female partners of child bearing potential must use highly effective birth control methods or have a sterilised partner for the duration of the study. Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include systemic hormonal contraceptives, intrauterine device or sexual abstinence.
  • •Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline.
  • •Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
  • •6\. Patients whose pre\-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
  • •7\. Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\. Patients who are known to be non\-compliant with dialysis treatment
  • •(i.e., has missed more than 2 dialysis sessions in the past 2 months
  • •because of non\-compliance).
  • •2\. Patients who are anticipated to receive a kidney transplant during the
  • •3\. Patients on peritoneal dialysis.
  • •4\. Patients with substantial residual renal output (\>300 ml per day).
  • •5\. Patients with pruritus only during the dialysis session (by patient
  • •6\. Patients with pruritus probably or definitely attributed to a cause
  • •other than end stage renal disease or its complications (e.g., patients
  • •with concomitant pruritic dermatological disease or cholestatic liver

Outcomes

Primary Outcomes

Not specified

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