Availability Study of ACTH to Treat Children SRNS/SDNS

Proteinuria Clinical Trial

Official title:

Availability and Safety Study of ACTH to Treat Children SRNS/SDNS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972346
• Other study ID #: XH-16-044
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: November 20, 2016
• Start date: November 2016
• Est. completion date: June 2019

Study information

• Verified date: November 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yufeng Li, Ph.D.
• Phone: 136517220156
• Email: mieuniversity[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proteinuria

Intervention

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

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour proteinuria excretion		1.5 years	Yes
Secondary	times of relapse		1.5 years	Yes