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Long Term Tapering or Standard Steroids for Nephrotic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Institute of Child Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308321
First Posted: March 29, 2006
Last Update Posted: November 29, 2007
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.
Information provided by:
Institute of Child Health
  Purpose
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 Intervention Phase
Nephrotic Syndrome Drug: long term tapering of prednisolone Drug: standard prednisolone treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

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

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

Estimated Enrollment: 50
Study Start Date: September 2003
Estimated Study Completion Date: October 2008
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
  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00308321


Contacts
Contact: Richard Trompeter 0121 333 8741 r.a.cook@bham.ac.uk

Locations
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
Investigators
Principal Investigator: Richard Trompeter Great Ormond Street Hospital
Principal Investigator: Peter Houtman Children's Hospital, Leicester
  More Information

Responsible Party: Tracy Assari, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00308321     History of Changes
Other Study ID Numbers: 03NU13
First Submitted: March 28, 2006
First Posted: March 29, 2006
Last Update Posted: November 29, 2007
Last Verified: November 2007

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