Long Term Tapering or Standard Steroids for Nephrotic Syndrome - Full Text View

Sponsored by:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00308321

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 IV

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Long Term Tapering or Standard Steroids for Nephrotic Syndrome

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:

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)

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Prednisolone acetate
Neuroprotective Agents

Glucocorticoids
Hormones
Nephrosis
Urologic Diseases
Prednisolone
Peripheral Nervous System Agents
Kidney Diseases
Nephrotic Syndrome
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones
Nephrosis
Pathologic Processes
Urologic Diseases
Syndrome
Therapeutic Uses

Kidney Diseases
Methylprednisolone Hemisuccinate
Disease
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Nephrotic Syndrome

ClinicalTrials.gov processed this record on May 06, 2009