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Long Term Tapering or Standard Steroids for Nephrotic Syndrome

NCT ID: NCT00308321

Last Updated: 2007-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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)

Intervention Type DRUG

standard prednisolone treatment

60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Institute of Child Health

Principal Investigators

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Richard Trompeter

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Peter Houtman

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Leicester

Locations

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Institute of Child Health

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Richard Trompeter

Role: CONTACT

Phone: 0121 333 8741

Email: [email protected]

Facility Contacts

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Dr Trompeter

Role: primary

References

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Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.

Reference Type DERIVED
PMID: 39171624 (View on PubMed)

Other Identifiers

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03NU13

Identifier Type: -

Identifier Source: org_study_id