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Availability Study of ACTH to Treat Children SRNS/SDNS

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ClinicalTrials.gov Identifier: NCT02972346
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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
Proteinuria Drug: ACTH Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: adrenocorticotropic hormone

No Intervention: ACTH(-)
routine treatment



Primary Outcome Measures :
  1. 24-hour proteinuria excretion [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. times of relapse [ Time Frame: 1.5 years ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02972346


Contacts
Contact: Yufeng Li, Ph.D. 136517220156 mieuniversity@hotmail.com
Contact: Yaju Zhu, MD 136501664385 yayastime@126.com

Locations
China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Beiqing Jiang    86-21-25078999    Xinhuakeyan@163.com   
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

Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02972346     History of Changes
Other Study ID Numbers: XH-16-044
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Urination Disorders
Proteinuria
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action