Trial | NCT00755859  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    206
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.
Study Started
May 31
1998
Primary Completion
Dec 31
2004
Study Completion
Sep 30
2007
Last Update
Sep 19
2008
Estimate

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

1 Experimental

Six month steroid course plus azathioprine

2 Active Comparator

six month steroid course

Criteria 

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
No Results Posted