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Steroids and Azathioprine in Advanced IgAN

NCT01392833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2011-07-13

No results posted yet for this study

Summary

Some years ago the investigators designed a randomised trial to prospectively evaluate whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine \<=2.0 mg/dl.

In order to test the efficacy of the combination of steroids with azathioprine at various degree of renal function deterioration by extending the trial to patients with more advanced disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal biopsy. Treatment will last one year: 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, then 0.2 mg/kg every other day for further 6 months. The primary outcome was renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes were proteinuria over time and the number and types of adverse events in the two groups assessed every month for the first six months, every two months from the 6th to the 12th month and every three months thereafter. The planned duration of follow up is five years.

Conditions

Interventions

DRUG

methylprednisolone

intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5

DRUG

azathioprine

azathioprine 1.5 mg/kg/day for six months followed by azathioprine 50 mg/day for a further six months.

DRUG

prednisone

prednisone 0.5 mg/kg every other day followed by prednisone 0.2 mg/kg every other day for a further six months.

Sponsors & Collaborators

  • A. Manzoni Hospital

    lead OTHER

Principal Investigators

  • claudio pozzi, md · A. Manzoni Hospital, ospedale G. bassini

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
1999-12-31
Primary Completion
2006-11-30
Completion
2008-01-31

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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 NCT01392833 on ClinicalTrials.gov