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"Steroids and Azathioprine Versus Steroids Alone in IgAN"

NCT00755859 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2008-09-19

No results posted yet for this study

Summary

In a previous trial the investigators found that the effect of steroids in IgA nephropathy diminish over time. The difference in renal survival is striking up till the third year, but then remains constant. A six-month course of steroid therapy may be not enough to ensure a stable remission. The investigators hypothesized that a more aggressive treatment may obtain long-term better results. The investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

Conditions

Interventions

DRUG

steroids plus azathioprine

methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day plus azathioprine 1.5 mg/kg/day for six months

DRUG

steroids

methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day for six months

Sponsors & Collaborators

  • A. Manzoni Hospital

    lead OTHER

Principal Investigators

  • Claudio Pozzi, MD · A Manzoni Hospital, Lecco, Italy

  • Francesco Locatelli, MD · A Manzoni Hospital, Lecco, Italy

  • Simeone Andrulli, MD · A Manzoni Hospital, Lecco, Italy

  • Antonello Pani, MD · Hospital "G. Brotzu", Cagliari, Italy

  • Paolo Altieri, MD · Hospital "G. Brotzu", Cagliari, Italy

  • Gian B Fogazzi, MD · Hospital "Maggiore" IRCCS, Milan, Italy

  • Claudio Ponticelli, MD · Hospital "Maggiore" IRCCS, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-05-31
Primary Completion
2004-12-31
Completion
2007-09-30

Countries

  • Italy
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755859 on ClinicalTrials.gov