MedDataX Logo

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

NCT ID: NCT04536181

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Steroid-Sensitive Nephrotic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3 months group

Subjects will receive 12-weeks of placebo following randomization

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

12 weeks simulated tablets

6 months group

12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone.

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

12 weeks prednisolone treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prednisolone

12 weeks prednisolone treatment

Intervention Type DRUG

Placebo

12 weeks simulated tablets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

prednisone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
* Age 12 months up to 6 years
* Written informed consent

Exclusion Criteria

* Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
* Therapy with prednisolone for prior episodes of nephrotic syndrome
* Persistent estimated glomerular filtration rate (GFR) \<75 ml/min/1.73 m2
* Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
* Patients with initial steroid resistance
* Patients who are allergic to glucocorticoids
* The compliance of patients or their guardians is poor
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong Xu, PhD.MD.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Children's Hospital

Shanghai, , China

Site Status

Shanghai Children's Medical Center

Shanghai, , China

Site Status

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSICS

Identifier Type: -

Identifier Source: org_study_id