Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:

Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00308321
• Other study ID #: 03NU13
• Status: Recruiting
• Phase: Phase 4
• First received: March 28, 2006
• Last updated: November 28, 2007
• Start date: September 2003
• Est. completion date: October 2008

Study information

• Verified date: November 2007
• Source: Institute of Child Health
• Contact: Richard Trompeter
• Phone: 0121 333 8741
• Email: r.a.cook[@]bham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Drug:
• long term tapering of prednisolone
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 treatment
60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8

Locations

Country	Name	City	State
United Kingdom	Institute of Child Health	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first relapse		5 months	No
Primary	Assessment of steroid induced morbidity		5 months	No
Secondary	frequent relapsing and steroid dependant disease		5 months	No
Secondary	Time to relapse		5 months	No
Secondary	serious adverse events		5 months	No
Secondary	use of other immunosuppressive agents		5 months	No
Secondary	Achenbach child behaviour checklist		5 months	No