CLINICAL TRIAL NO: EU820UPV01 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TRK-820 IN HEMODIALYSIS PATIENTS WITH UREMIC PRURITUS EudraCT No: 2005-003469-18 Short Title: TRK-820 UP 5µg - TRK-820 UP 5µg

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2005-003469-18-BE
• Date of registration: 13/10/2005
• Prospective Registration: Yes
• Primary sponsor: Toray Industries, Inc.
• Public title: CLINICAL TRIAL NO: EU820UPV01 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TRK-820 IN HEMODIALYSIS PATIENTS WITH UREMIC PRURITUS EudraCT No: 2005-003469-18 Short Title: TRK-820 UP 5µg - TRK-820 UP 5µg
• Scientific title: CLINICAL TRIAL NO: EU820UPV01 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TRK-820 IN HEMODIALYSIS PATIENTS WITH UREMIC PRURITUS EudraCT No: 2005-003469-18 Short Title: TRK-820 UP 5µg - TRK-820 UP 5µg
• Date of first enrolment: 19/10/2005
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003469-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Czech Republic, Italy, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
1.Male and female patients at least 18 years of age.
2.Patient has a clinical diagnosis of UP due to ESRD which is uncontrolled by current medication(s) and/or treatment(s).
3.Patient on regular hemodialysis (or hemofiltration or hemodiafiltration), i.e. three times a week with a minimum duration of 12 hours per week and a minimum Kt/V of 1.2 for at least two months prior to the start of the one week run-in period.
4.Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study (e.g. hormonal contraceptives, contraceptive coil). Male and female patients must practice effective birth control during the study.
5.Patient capable of understanding the purposes and risks of the trial and has given written informed consent.
6.Patient has not taken, and agrees not to take, any medication or therapy prohibited by the protocol for the complete study period.

In order to qualify for treatment, patient must meet all of the following criteria at the end of the one week run-in period:
7.Patient completed ratings of worst itching intensity (VAS) at least 8 times out of 14 VAS assessments during the one week run-in period.
8.Patient has at least 3 VAS ratings of = 50 mm during the one week run-in period.
9.Patient has a mean value of > 25 mm on the worst itching VAS during the one week run-in period.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Patient has pruritus other than secondary to ESRD.
2.Patient has pruritus only during the dialysis sessions.
3.Patient has an abnormal hepatic function based on an overall assessment by the investigator regarding medical history, physical examination and laboratory tests of hepatic function (ALT > 3 ULN, AST > 3 ULN).
4.Patient has a diagnosis of a malignant tumor.
5.Patient has an acute medical condition within 30 days prior the start of the one week run in period (Note: Subjects with an acute medical illness between screening and randomization must be re-screened after approval from the medical monitor).
6.Patient has an advanced, severe or unstable disease of any type other than ESRD (e.g. advanced chronic heart failure NYHA class III or IV, unstable angina, uncontrolled hypertension, uncontrolled diabetes mellitus, severe asthma).
7.Female patients who are pregnant or breast-feeding mothers.
8.Patient has any form of substance abuse/addiction (including drug or alcohol abuse) or psychiatric disorder or condition, which, in the opinion of the investigator, would prevent them from complying with the procedures detailed in the protocol.
9.Patient has a known hypersensitivity to opioids or the ingredients of the study medication.
10.Patient is taking any prohibited concomitant medication (please refer to section 7.2).
11. Patient is participating in another clinical trial (investigational drug or device) or was participating within 21 days prior the start of the one week run-in period.
12. Patient has a history of emotional instability or psychiatric disorder that makes them unsuitable for inclusion in the study.
13. Patient has already participated in a clinical study with TRK-820.
In order to qualify for treatment, patient must not meet the following criterion at the end of the one week run-in period:
14. Patient has started any new emollient or oil bath within one week prior to the start of the one week run-in period.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients on hemodialysis three times a week suffering from Uremic Pruritus (UP), uncontrolled by current medication(s) and/or treatment(s), will be enrolled.

Intervention(s)

Product Name: Nalfurafine Hydrochloride
Product Code: TRK-820
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nalfurafine
Current Sponsor code: TRK-820
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): The change in worst itching recorded on the Visual Analogue Scale (VAS) from baseline, which is the one week run-in period, to the end of Week 4

Main Objective: To compare the efficacy of three times a week i.v. treatment with TRK-820 5µg versus placebo in hemodialysis patients with UP following completion of a four-week parallel-group treatment period.

Previously conducted Phase III studies showed a trend towards statistically significant results on efficacy for i.v. 5µg TRK-820 three times a week over placebo in a parallel group study with four weeks treatment as well as in a cross-over study with treatment periods of two weeks each.

Secondary Objective: ·To investigate the efficacy of i.v. TRK-820 5µg over an 8-week treatment period.
·To investigate the maintenance of efficacy of i.v. TRK-820 5µg following a re randomization of the TRK-820 patients to continued i.v. TRK-820 5µg or placebo from Week 8 to Week 12.
·To assess the safety of i.v. TRK-820 5µg.
·To determine the pharmacokinetic (PK) characteristics of i.v. TRK-820 5µg in approximately 30 patients with UP on regular hemodialysis.

Secondary ID(s)

2005-003469-18-LT

EU820UPV01