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Prednisolone Trial in Children Younger Than 4 Years

NCT03141970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-01-30

No results posted yet for this study

Summary

This study is a multicentric, randomized, parallel group, open label controlled trial of children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is designed to test the initial duration of steroid therapy of either 3 month or 6 month total duration. Participants will be randomized to either extend their pre-trial 3 months (12 weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6 weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these children with idiopathic nephrotic syndrome.

Conditions

  • Nephrotic Syndrome

Interventions

DRUG

Prednisolone

Prednisolone for 12 weeks as follows 30 mg/m2 on alternate days for 4 weeks 20 mg/m2 on alternate days for 4 weeks 10 mg/m2 on alternate days for 4 weeks

Sponsors & Collaborators

  • NephCure Accelerating Cures Institute

    collaborator UNKNOWN

  • University of Michigan

    collaborator OTHER

  • Department of Biotechnology, Government of India (funding agency)

    collaborator UNKNOWN

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Arvind Bagga, MD · All India Institute of Medical Sciences, New Delhi, India

  • Debbie Gipson, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2020-10-31
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141970 on ClinicalTrials.gov