Availability Study of ACTH to Treat Children SRNS/SDNS

Overview

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.

Full Title of Study: “Availability and Safety Study of ACTH to Treat Children SRNS/SDNS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: ACTH(+)
    • routine treatment + ACTH
  • No Intervention: ACTH(-)
    • routine treatment

Clinical Trial Outcome Measures

Primary Measures

  • 24-hour proteinuria excretion
    • Time Frame: 1.5 years

Secondary Measures

  • times of relapse
    • Time Frame: 1.5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yufeng Li, Ph.D., Study Director, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Overall Contact(s)
    • Yufeng Li, Ph.D., 136517220156, mieuniversity@hotmail.com

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