NCT04713410

Brief Summary

All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time will be divided into two groups. One group will be given steroids for 12 weeks and other group will receive steroid for 20 weeks. During the 1 years after completion of steroid course patients will be monitor for the episodes of relapse in both group.

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

January 14, 2021

Last Update Submit

May 9, 2021

Conditions

Steroid-Sensitive Nephrotic Syndrome

Keywords

Nephrotic Syndrome, steroid response, relapse

Outcome Measures

Primary Outcomes (1)

  • Relapse rate

    Relapse rete

    2 years

Study Arms (2)

Group A

EXPERIMENTAL

Steroids will be given for short duration of time i-e 12 weeks

Drug: Prednisolone

Group B

ACTIVE COMPARATOR

Steroid will be given for longer duration i-e 20 weeks

Drug: Prednisolone

Interventions

PrednisoloneDRUG

Regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day.

Group AGroup B

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 1 to 8 years of age,
  • Diagnose with nephrotic syndrome for the first time
  • Steroid sensitive nephrotic syndrome

You may not qualify if:

  • Steroid resistant nephrotic syndrome
  • Steroid dependent nephrotic syndrome
  • Syndromic Children
  • Children with other co morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Capital, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Nephrotic SyndromeRecurrence

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

December 22, 2020

Primary Completion

September 4, 2022

Study Completion

September 4, 2023

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

PA(1)