Availability Study of ACTH to Treat Children SRNS/SDNS

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02972346

Enrollment

Registered

2016-11-23

Start date

2016-11-30

Completion date

2019-06-30

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proteinuria

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.

Interventions

DRUGACTH

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame
24-hour proteinuria excretion	1.5 years

Secondary

Measure	Time frame
times of relapse	1.5 years

Countries

China

Contacts

Primary ContactYufeng Li, Ph.D.

mieuniversity@hotmail.com136517220156

Backup ContactYaju Zhu, MD

yayastime@126.com136501664385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026