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A Clinical Study of Tranilast in the Treatment of Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tranilast
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Tranilast, skin, lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months.

Exclusion Criteria:

  • 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tranilast

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in the size of the pulmonary nodule by ultrasound
    During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.
    Changes of the forced vital capacity(FVC)
    During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2018
    Last Updated
    May 6, 2018
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03528070
    Brief Title
    A Clinical Study of Tranilast in the Treatment of Sarcoidosis
    Official Title
    A Clinical Study of Tranilast in the Treatment of Sarcoidosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    56 patients with sarcoidosis will be selected to receive treatment of tranilast.The investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.
    Detailed Description
    56 patients with sarcoidosis will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(FVC), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(FVC). With 3 month as a time point, participants were observed for four points(one point if only skin invasion ).After the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcoidosis
    Keywords
    Sarcoidosis, Tranilast, skin, lung

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranilast
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tranilast
    Intervention Description
    Subjects will be treated with tranilast
    Primary Outcome Measure Information:
    Title
    Changes in the size of the pulmonary nodule by ultrasound
    Description
    During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.
    Time Frame
    12 months
    Title
    Changes of the forced vital capacity(FVC)
    Description
    During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months. Exclusion Criteria: 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maihua Hou, professor
    Phone
    +86 13776635881
    Email
    houmaihua@jsph.org.cn

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Study of Tranilast in the Treatment of Sarcoidosis

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