"Steroids and Azathioprine Versus Steroids Alone in IgAN"

This study has been completed.
Sponsor:
Information provided by:
A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT00755859
First received: September 18, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

September 18, 2008
September 18, 2008
May 1998
December 2004   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: No ]
  • safety [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
"Steroids and Azathioprine Versus Steroids Alone in IgAN"
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
IGA Nephropathy
  • 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:
    • solumedrol
    • deltacortene
    • azatioprina
  • 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:
    • solumedrol
    • deltacortene
  • Experimental: 1
    Six month steroid course plus azathioprine
    Intervention: Drug: steroids plus azathioprine
  • Active Comparator: 2
    six month steroid course
    Intervention: Drug: steroids
Locatelli F, Pozzi C, Del Vecchio L, Andrulli S, Pani A, Fogazzi G, Altieri P, Ponticelli C. Combined treatment with steroids and azathioprine in IgA nephropathy: design of a prospective randomised multicentre trial. J Nephrol. 1999 Sep-Oct;12(5):308-11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
September 2007
December 2004   (final data collection date for primary outcome measure)

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
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Switzerland
 
NCT00755859
IgANSTAZA
Yes
Claudio Pozzi, A. Manzoni Hospital, Lecco, Italy
A. Manzoni Hospital
Not Provided
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
A. Manzoni Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP