MedDataX Logo

Safety Study of TRK-820 for Patient With Hemodialysis

NCT ID: NCT01248650

Last Updated: 2010-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Safety evaluation Pharmacokinetic analysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TRK-820 5 μg

Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route

Group Type ACTIVE_COMPARATOR

nalfurafine hydrochloride

Intervention Type DRUG

TRK-820 2.5μg

Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route

Group Type ACTIVE_COMPARATOR

nalfurafine hydrochloride

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nalfurafine hydrochloride

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toray Industries, Inc

INDUSTRY

Sponsor Role collaborator

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SK Chemicals Co.,Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wooseong Huh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRK-820_HD_I_2008

Identifier Type: -

Identifier Source: org_study_id