Availability Study of ACTH to Treat Children SRNS/SDNS

Not Applicable

• Conditions: Proteinuria
• Interventions: Drug: ACTH

• Registration Number: NCT02972346
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-20
• Last Update Submitted: 2016-11-20
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTH(+)	ACTH	routine treatment + ACTH

Primary Outcome Measures

Name	Time	Method
24-hour proteinuria excretion	1.5 years

Secondary Outcome Measures

Name	Time	Method
times of relapse	1.5 years

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China