Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

NCT04536181 | Withdrawn Phase 3

• 1 other identifier: CSICS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Steroid-Sensitive Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment

  Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.

  12 month period after 3 month standard treatment

Secondary Outcomes (7)

• Number of relapses during 12 months follow up after 3 month standard treatment

  12 month period after 3 month standard treatment

• Time to first relapse (days)

  12 month period after 3 month standard treatment

• Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment

  12 month period after 3 month standard treatment

• The use of steroid-sparing medications

  12 month period after 3 month standard treatment

• Adverse events during 12-month period after 3 month standard treatment

  12 month period after 3 month standard treatment

Study Arms (2)

3 months group

PLACEBO COMPARATOR

Subjects will receive 12-weeks of placebo following randomization

Drug: Placebo

6 months group

EXPERIMENTAL

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

Drug: Prednisolone

Interventions

Prednisolone DRUG

12 weeks prednisolone treatment

Also known as: prednisone

6 months group

Placebo DRUG

12 weeks simulated tablets

3 months group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (4)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Children's Hospital

Shanghai, China

Location

Shanghai Children's Medical Center

Shanghai, China

Location

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Prednisolone; Prednisone

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Hong Xu, PhD.MD.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 2, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)