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Availability Study of ACTH to Treat Children SRNS/SDNS

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT02972346
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
30.9
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this multicenter, prospective case series of prescription based treatment with ACTH for NS.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Availability and Safety Study of ACTH to Treat Children SRNS/SDNS
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACTH(+)

routine treatment + ACTH

Drug: ACTH
routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks
Other Names:
  • adrenocorticotropic hormone

    		•
    No Intervention: ACTH(-)

    routine treatment

    Outcome Measures

    Primary Outcome Measures

    1. 24-hour proteinuria excretion [1.5 years]

    Secondary Outcome Measures

    1. times of relapse [1.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. age:3-12 years old

    2. primary nephrotic syndrome

    3. SRNS or SDNS

    4. Minor lesion or minimal change disease

    5. Signed informed consent

    Exclusion Criteria:

    1. Second nephrotic syndrome

    2. allergic to ACTH

    3. Refuse to signed informed consent

    4. have had ACTH treatment

    5. serious complication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinhua Hospital Shanghai Shanghai China 200092

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    • Study Director: Yufeng Li, Ph.D., Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02972346
    Other Study ID Numbers:
    • XH-16-044
    First Posted:
    Nov 23, 2016
    Last Update Posted:
    Nov 23, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Proteinuria
    Adrenocorticotropic Hormone
    Melanocyte-Stimulating Hormones
    beta-Endorphin

    Study Results

    No Results Posted as of Nov 23, 2016