Status:
COMPLETED
Safety Study of TRK-820 for Patient With Hemodialysis
Lead Sponsor:
SK Chemicals Co., Ltd.
Collaborating Sponsors:
Toray Industries, Inc
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
Eligibility Criteria
Inclusion
- Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
- Patients aged 20 years or older
- Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 \~ 130 %
- Patients who can understand and follow instructions and participate in the study during the entire study period
- Patients who signed the informed consent form before participating in the study
Exclusion
- Patients who have confirmed malignant tumor
- Patients with cognitive impairment including depression, schizophrenia and dementia
- Patients with hepatic cirrhosis as a complication
- Patients with drug allergy to opioids
- Patients with drug dependency or allergic disease (including skin response to UV radiation)
- Patients who participated in other study and received the investigational drug within 1 month before the signing day
- Patients who participated in other TRK-820 study within 4 weeks before the signing day
- Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception
- Patients who received any of the following drugs within 2 weeks before Day 1
- Azole antifungal agents
- Ketoconazole
- Fluconazole
- Itraconazole
- Clotrimazole
- Macrolide antibiotics
- Erythromycin
- Midecamycin
- Josamycin
- Roxithromycin
- Clarithromycin
- Triacetyloleandomycin
- Ritonavir
- Cyclosporine
- Nifedipine
- Cimetidine
- Amiodarone
- Patients who had the following drinks and foods within 2 weeks before Day 1
- Foods and drinks containing grape fruit juice
- Food and drinks containing St. John's wort
- Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
- Patients who smoked and drank from three months before the signing day
- Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01248650
Start Date
December 1 2008
End Date
December 1 2008
Last Update
November 25 2010
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea