Availability Study of ACTH to Treat Children SRNS/SDNS

Shanghai Jiao Tong University

Status: Unknown

Conditions: Proteinuria

Treatments: Drug: ACTH

Study type: Interventional

Funder types: Other

Identifiers

NCT02972346

XH-16-044

Details and patient eligibility

About

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 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

ACTH(+)

Experimental group

Description:

routine treatment + ACTH

Treatment:

Drug: ACTH

ACTH(-)

No Intervention group

Description:

routine treatment