Back to resultsLong Term Tapering or Standard Steroids for Nephrotic Syndrome
Primary Purpose
Nephrotic Syndrome
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
long term tapering of prednisolone
standard prednisolone treatment
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome
Eligibility Criteria
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
Sites / Locations
- Institute of Child HealthRecruiting
Outcomes
Primary Outcome Measures
Time to first relapse
Assessment of steroid induced morbidity
Secondary Outcome Measures
frequent relapsing and steroid dependant disease
Time to relapse
serious adverse events
use of other immunosuppressive agents
Achenbach child behaviour checklist
Full Information
NCT ID
NCT00308321
First Posted
March 28, 2006
Last Updated
November 28, 2007
Sponsor
Institute of Child Health
1. Study Identification
Unique Protocol Identification Number
NCT00308321
Brief Title
Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Official Title
Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Child Health
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
long term tapering of prednisolone
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
standard prednisolone treatment
Intervention Description
60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8
Primary Outcome Measure Information:
Title
Time to first relapse
Time Frame
5 months
Title
Assessment of steroid induced morbidity
Time Frame
5 months
Secondary Outcome Measure Information:
Title
frequent relapsing and steroid dependant disease
Time Frame
5 months
Title
Time to relapse
Time Frame
5 months
Title
serious adverse events
Time Frame
5 months
Title
use of other immunosuppressive agents
Time Frame
5 months
Title
Achenbach child behaviour checklist
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Trompeter
Phone
0121 333 8741
Email
r.a.cook@bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Trompeter
Organizational Affiliation
Great Ormond Street Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Houtman
Organizational Affiliation
Children's Hospital, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Child Health
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Trompeter
First Name & Middle Initial & Last Name & Degree
Richard Trompeter
12. IPD Sharing Statement
Learn more about this trial
Long Term Tapering or Standard Steroids for Nephrotic Syndrome
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