Moderate to Severe Uremic Pruritus MedDRA version: 20.0 Level: LLT Classification code 10060884 Term: Uremic pruritus System Organ Class: 100000004858
Conditions
Interventions
Product Name: Dihomo-Gamma-Linolenic Acid, DGLA
Product Code: DS107G
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: not applicable
Other descriptive name: DIHOMO-GAMMA-LINOLENIC ACID (DGLA)
C
Sponsors
DS Biopharma
Eligibility
Sex/Gender
All
Inclusion 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 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 adequate contraception or have a sterilised partner for the duration of the study. Adequate contraception is defined as: systemic hormonal contraceptives, intrauterine device or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at least one month before baseline. 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 study. 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 report). 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 disease will be excluded). 7. Patients with a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the reference upper limit of normal (ULN), or total bilirubin greater than 2 times ULN at screening. 8. Patients with a history of clinically significant drug or alcohol abuse in the opinion of the investigator in the last year prior to Baseline (Day 0). 9. Patients using any topical agents with potential antipruritic activity, excluding emollients, during the 2 weeks before the baseline visit. 10. Patients with systemic antipruritic treatment during the 2 weeks before the baseline visit. Second and third generation oral antihistamines are allowed if the patient is on stable dose of antihistamine and this dose is not changed during the study period. First generation oral antihistamines are disallowed. 11. Patients on immuno-suppressant treatment such as Cyclosporine A (CsA), Methotrexate, Glucocorticoid steroids and similar compounds. 12. Patients who have received ultraviolet B treatment in the 4 weeks prior to the start of Screening or anticipated to receive such treatment during the study. 13. Patients who have participated in any other clinical study with an investigational medicinal product (IMP) within 3 months before the first day of administration of study treatment. 14. Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in inclusion criterion 5) during the trial. 15. Patients, in the opinion of the Investigator, not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 12;Main Objective: To compare the efficacy of orally administered DS107 versus placebo, in the treatment of adult haemodialysis patients with moderate to severe Uremic Pruritus (UP).;Secondary Objective: To assess the safety of orally administered DS107 versus placebo, in adult haemodialysis patients with UP.;Primary end point(s): Change from baseline in worst-itching over the last 24 hours on the 11- point Numerical Rating Scale (NRS) in DS107 treated population compared to placebo at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change from baseline in mean itching over the last 24 hours on the 11 point NRS in DS107 treated population compared to placebo at Week 2, 4, 6, 8, 10, 12 and 14. ? Change from Week 12 (end of treatment/early termination visit) in worst-itching on the 11-point NRS in DS107 treated population compared to placebo at Week 14 (follow-up). ? Change from baseline in worst-itching on the 11-point NRS in DS107 treated population compared to placebo at Week 2, 4, 6, 8, 10 and 14. ? Percentage of patients achieving improvement of pruritus of at least 2.7 points based on NRS at Week 2, 4, 6, 8, 10, 12 and 14. ? Change from baseline in worst itching on the Dynamic Pruritus Score DPS) in DS107 treated population compared to placebo at Week 2, 4, 6, 8, 10, 12 and 14. ? Change from baseline in ItchyQoL assessment in DS107 treated population compared to placebo population from baseline to Week 2, 4, 6, 8, 10, 12 and 14. ? Change in sleep quality assessment in DS107 treated population compared to placebo population from baseline to Week 2, 4, 6, 8, 10, 12 and 14. ? Change in xerosis scoring in DS107 treated population compared to placebo population from baseline to Week 2, 4, 6, 8, 10, 12 and 14. ? Change from baseline to Week 2, 4, 6, 8, 10, 12 and 14, in worstitching on the 11-point NRS in the DS107 treated population compared to placebo treated sub-populations of subjects with a normal white blood cell count defined by a white blood cell (WBC) count of 3.5 -11.1 x109/L and a Neutrophil count of 1.8 -7.0 x109/L ? Change from baseline to Week 2, 4, 6, 8, 10, 12 and 14, in worstitching on the 11-point NRS in the DS107 treated population compared to placebo treated sub-populations of subjects with a normal eosinophil count (< 0.3 x109/L). ;Timepoint(s) of evaluation of this end point: Week 2, 4, 6, 8, 10, 12 and 14 | — |
Countries
Estonia, Germany, Latvia, Poland, Ukraine
Contacts
Public ContactClinical Trials Information
DS Biopharma
Outcome results
None listed