Availability Study of ACTH to Treat Children SRNS/SDNS
Primary Purpose
Proteinuria
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ACTH
Sponsored by
About this trial
This is an interventional treatment trial for Proteinuria
Eligibility Criteria
Inclusion Criteria:
- age:3-12 years old
- primary nephrotic syndrome
- SRNS or SDNS
- Minor lesion or minimal change disease
- Signed informed consent
Exclusion Criteria:
- Second nephrotic syndrome
- allergic to ACTH
- Refuse to signed informed consent
- have had ACTH treatment
- serious complication
Sites / Locations
- Xinhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACTH(+)
ACTH(-)
Arm Description
routine treatment + ACTH
routine treatment
Outcomes
Primary Outcome Measures
24-hour proteinuria excretion
Secondary Outcome Measures
times of relapse
Full Information
NCT ID
NCT02972346
First Posted
November 17, 2016
Last Updated
November 20, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02972346
Brief Title
Availability Study of ACTH to Treat Children SRNS/SDNS
Official Title
Availability and Safety Study of ACTH to Treat Children SRNS/SDNS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTH(+)
Arm Type
Experimental
Arm Description
routine treatment + ACTH
Arm Title
ACTH(-)
Arm Type
No Intervention
Arm Description
routine treatment
Intervention Type
Drug
Intervention Name(s)
ACTH
Other Intervention Name(s)
adrenocorticotropic hormone
Intervention Description
routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks
Primary Outcome Measure Information:
Title
24-hour proteinuria excretion
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
times of relapse
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age:3-12 years old
primary nephrotic syndrome
SRNS or SDNS
Minor lesion or minimal change disease
Signed informed consent
Exclusion Criteria:
Second nephrotic syndrome
allergic to ACTH
Refuse to signed informed consent
have had ACTH treatment
serious complication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yufeng Li, Ph.D.
Phone
136517220156
Email
mieuniversity@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaju Zhu, MD
Phone
136501664385
Email
yayastime@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yufeng Li, Ph.D.
Organizational Affiliation
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beiqing Jiang
Phone
86-21-25078999
Email
Xinhuakeyan@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Availability Study of ACTH to Treat Children SRNS/SDNS
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