Availability Study of ACTH to Treat Children SRNS/SDNS | NCT02972346

Studies
Availability Study of ACTH to Treat Children SRNS/SDNS

NCT02972346

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Nov 23, 2016Estimated

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Proteinuria

Interventions

ACTH

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Nov 17, 2016

First Submission Date that Met QC Criteria

Nov 20, 2016

First Posted Date

Nov 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2016

Last Update Posted Date

Nov 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACTH(+)	Experimental	routine treatment + ACTH	Drug: ACTH
ACTH(-)	No Intervention	routine treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACTH	Drug	routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks	ACTH(+)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour proteinuria excretion		1.5 years

Secondary Outcomes

Measure	Description	Time Frame
times of relapse		1.5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yufeng Li, Ph.D.	Contact	136517220156		mieuniversity@hotmail.com
Yaju Zhu, MD	Contact	136501664385		yayastime@126.com

Overall Officials

Name	Affiliation	Role
Yufeng Li, Ph.D.	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinhua Hospital	Recruiting	Shanghai	Shanghai Municipality	200092	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39513526	Derived	Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones