NCT02972346

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

November 17, 2016

Last Update Submit

November 20, 2016

Conditions

Proteinuria

Outcome Measures

Primary Outcomes (1)

  • 24-hour proteinuria excretion

    1.5 years

Secondary Outcomes (1)

  • times of relapse

    1.5 years

Study Arms (2)

ACTH(+)

EXPERIMENTAL

routine treatment + ACTH

Drug: ACTH

ACTH(-)

NO INTERVENTION

routine treatment

Interventions

ACTHDRUG

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

Also known as: adrenocorticotropic hormone
ACTH(+)

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age:3-12 years old
  • primary nephrotic syndrome
  • SRNS or SDNS
  • Minor lesion or minimal change disease
  • Signed informed consent

You may not qualify if:

  • Second nephrotic syndrome
  • allergic to ACTH
  • Refuse to signed informed consent
  • have had ACTH treatment
  • serious complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39513526DERIVED

MeSH Terms

Conditions

Proteinuria

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Yufeng Li, Ph.D.

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Yufeng Li, Ph.D.

CONTACT

136517220156mieuniversity@hotmail.com

Yaju Zhu, MD

CONTACT

136501664385yayastime@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

November 23, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)