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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
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tracy Assari, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00308321     History of Changes
Other Study ID Numbers: 03NU13
Study First Received: March 28, 2006
Last Updated: November 28, 2007
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013