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Long Term Tapering or Standard Steroids for Nephrotic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Institute of Child Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00308321
First received: March 28, 2006
Last updated: November 28, 2007
Last verified: November 2007
History of Changes

March 28, 2006
November 28, 2007
September 2003
Not Provided
  • Time to first relapse [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Assessment of steroid induced morbidity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Time to first relapse
  • Assessment of steroid induced morbidity
Complete list of historical versions of study NCT00308321 on ClinicalTrials.gov Archive Site
  • frequent relapsing and steroid dependant disease [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Time to relapse [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • serious adverse events [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • use of other immunosuppressive agents [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Achenbach child behaviour checklist [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • frequent relapsing and steroid dependant disease
  • Time to relapse
  • serious adverse events
  • use of other immunosuppressive agents
  • Achenbach child behaviour checklist
Not Provided
Not Provided
 
Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Long Term Tapering or Standard Steroids for Nephrotic Syndrome

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nephrotic Syndrome
  • 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)
  • Drug: standard prednisolone treatment
    60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2008
Not Provided

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
Both
1 Year to 15 Years
No
Contact: Richard Trompeter 0121 333 8741 r.a.cook@bham.ac.uk
United Kingdom
 
NCT00308321
03NU13
Not Provided
Tracy Assari, Institute of Child Health
Institute of Child Health
Not Provided
Principal Investigator: Richard Trompeter Great Ormond Street Hospital
Principal Investigator: Peter Houtman Children's Hospital, Leicester
Institute of Child Health
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP