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Safety Study of TRK-820 for Patient With Hemodialysis (TRK-820)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248650
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : November 25, 2010
Toray Industries, Inc
Information provided by:
SK Chemicals Co., Ltd.

Brief Summary:
The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: nalfurafine hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis
Study Start Date : December 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: TRK-820 5 μg
Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route
Drug: nalfurafine hydrochloride
Active Comparator: TRK-820 2.5μg
Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route
Drug: nalfurafine hydrochloride

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

    1. Azole antifungal agents

      1. Ketoconazole
      2. Fluconazole
      3. Itraconazole
      4. Clotrimazole
    2. Macrolide antibiotics

      1. Erythromycin
      2. Midecamycin
      3. Josamycin
      4. Roxithromycin
      5. Clarithromycin
      6. Triacetyloleandomycin
    3. Ritonavir
    4. Cyclosporine
    5. Nifedipine
    6. Cimetidine
    7. Amiodarone
  • Patients who had the following drinks and foods within 2 weeks before Day 1

    1. Foods and drinks containing grape fruit juice
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248650

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Toray Industries, Inc
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Principal Investigator: Wooseong Huh, MD, PhD Samsung Medical Center

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Responsible Party: Hogan Park, SK Chemicals Co.,Ltd. Identifier: NCT01248650     History of Changes
Other Study ID Numbers: TRK-820_HD_I_2008
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2009
Keywords provided by SK Chemicals Co., Ltd.:
Safety evaluation
Pharmacokinetic analysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic