NCT00308321

Brief Summary

Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime

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
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4

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

September 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

March 28, 2006

Last Update Submit

November 28, 2007

Conditions

Nephrotic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Time to first relapse

    5 months

  • Assessment of steroid induced morbidity

    5 months

Secondary Outcomes (5)

  • frequent relapsing and steroid dependant disease

    5 months

  • Time to relapse

    5 months

  • serious adverse events

    5 months

  • use of other immunosuppressive agents

    5 months

  • Achenbach child behaviour checklist

    5 months

Interventions

long term tapering of prednisoloneDRUG

60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16)

standard prednisolone treatmentDRUG

60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio \>200mg/mmol on early morning urine sample, hypoalbuminemia (\<25g/L)

You may not qualify if:

  • prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health

London, WC1N 1EH, United Kingdom

RECRUITING

Related Publications (1)

  • Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.

    PMID: 39171624DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Richard Trompeter

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

  • Peter Houtman

    Children's Hospital, Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Trompeter

CONTACT

0121 333 8741r.a.cook@bham.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

September 1, 2003

Study Completion

October 1, 2008

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

GB(1)