Long Term Tapering or Standard Steroids for Nephrotic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308321
Recruitment Status : Unknown
Verified November 2007 by Institute of Child Health.
Recruitment status was:  Recruiting
First Posted : March 29, 2006
Last Update Posted : November 29, 2007
Information provided by:
Institute of Child Health

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

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: long term tapering of prednisolone Drug: standard prednisolone treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Study Start Date : September 2003
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Time to first relapse [ Time Frame: 5 months ]
  2. Assessment of steroid induced morbidity [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. frequent relapsing and steroid dependant disease [ Time Frame: 5 months ]
  2. Time to relapse [ Time Frame: 5 months ]
  3. serious adverse events [ Time Frame: 5 months ]
  4. use of other immunosuppressive agents [ Time Frame: 5 months ]
  5. Achenbach child behaviour checklist [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308321

Contact: Richard Trompeter 0121 333 8741

United Kingdom
Institute of Child Health Recruiting
London, United Kingdom, WC1N 1EH
Contact: Dr Trompeter         
Principal Investigator: Richard Trompeter         
Sponsors and Collaborators
Institute of Child Health
Principal Investigator: Richard Trompeter Great Ormond Street Hospital
Principal Investigator: Peter Houtman Children's Hospital, Leicester

Responsible Party: Tracy Assari, Institute of Child Health Identifier: NCT00308321     History of Changes
Other Study ID Numbers: 03NU13
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Nephrotic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents