"Steroids and Azathioprine Versus Steroids Alone in IgAN"

September 18, 2008 updated by: A. Manzoni Hospital

Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. However, the effect of steroids seemed to diminish over time. The difference in renal survival was particularly striking up till the third year, but then remained constant. We hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. At this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. However, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. We conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • Hospital "Spedali Civili"
      • Cagliari, Italy
        • "G. Brotzu" Hospital
      • Catania, Italy
        • Hospital "Cannizzaro"
      • Firenze, Italy
        • Hospital "Careggi"
      • Foggia, Italy
        • Hospital of University
      • Mantova, Italy
        • Hospital "C. Poma"
      • Nuoro, Italy
        • Hospital "S. Francesco"
      • Palermo, Italy
        • Hospital "V. Cervello"
      • Parma, Italy
        • University Hospital
      • Pavia, Italy
        • Fondazione Maugeri" IRCCS
      • Reggio Calabria, Italy
        • CNR-IBIM
      • Reggio Emilia, Italy
        • Hospital "S. Maria Nuova"
      • Sondrio, Italy
        • Hospital of Sondrio
      • Torino, Italy
        • CMID
      • Viterbo, Italy
        • Hospital "Belcolle"
    • BG
      • Seriate, BG, Italy
        • Hospital "Bolognini"
    • Brescia
      • Montichiari, Brescia, Italy
        • Hospital of Montichiari
    • CO
      • Como, CO, Italy, 22100
        • Hospital "S.Anna"
    • CR
      • Cremona, CR, Italy
        • Hospital "Istituti Ospitalieri"
    • CT
      • Acireale, CT, Italy
        • Hospital "S.Marta e S.Venera",
      • Taormina, CT, Italy
        • Hospital "S.Vincenzo"
    • LC
      • Lecco, LC, Italy, 23900
        • Department of Nephrology and Dialysis, A. Manzoni Hospital
    • LO
      • Lodi, LO, Italy
        • Hospital "Maggiore"
    • MI
      • Cernusco sul Naviglio, MI, Italy
        • Hospital "Uboldo"
      • Desio, MI, Italy
        • Hospital of Desio
      • Milano, MI, Italy
        • Hospital "Maggiore" IRCCS
    • Nuoro
      • Ozieri, Nuoro, Italy
        • Hospital "A.Segni"
  • Switzerland
      • Bern, Switzerland
        • Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • biopsy proven IgA nephropathy
  • creatinine ≤ 2.0 mg/dl for at least three months
  • proteinuria ≥ 1.0 g/day for at least three months

Exclusion Criteria:

  • treatment with steroids or cytotoxic drugs during the previous three years
  • contraindications to steroids or azathioprine
  • Henoch-Schöenlein purpura
  • diabetes mellitus
  • severe hypertension (diastolic blood pressure > 120 mmHg)
  • lupus erythematosus systemicus
  • malignancies
  • active peptic-ulcer disease
  • pregnancy
  • viral hepatitis or other infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Six month steroid course plus azathioprine
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
Other Names:
  • deltacortene
  • solumedrol
  • azatioprina
ACTIVE_COMPARATOR: 2
six month steroid course
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
Other Names:
  • deltacortene
  • solumedrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.
Time Frame: Every month for the first six months, then six months
Every month for the first six months, then six months

Secondary Outcome Measures

Outcome Measure
Time Frame
evolution of proteinuria over time
Time Frame: every months for the first six months and then every six months
every months for the first six months and then every six months
safety
Time Frame: every months for the first six months and then every six months
every months for the first six months and then every six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A. Manzoni Hospital

Investigators

  • Principal Investigator: Claudio Pozzi, MD, A Manzoni Hospital, Lecco, Italy
  • Study Chair: Francesco Locatelli, MD, A Manzoni Hospital, Lecco, Italy
  • Study Director: Simeone Andrulli, MD, A Manzoni Hospital, Lecco, Italy
  • Study Director: Antonello Pani, MD, Hospital "G. Brotzu", Cagliari, Italy
  • Study Director: Paolo Altieri, MD, Hospital "G. Brotzu", Cagliari, Italy
  • Study Director: Gian B Fogazzi, MD, Hospital "Maggiore" IRCCS, Milan, Italy
  • Study Director: Claudio Ponticelli, MD, Hospital "Maggiore" IRCCS, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (ESTIMATE)

September 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgANSTAZA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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