IGA Nephropathy
Conditions
Keywords
IgA nephropathy, steroids, azathioprine, chronic kidney disease progression, proteinuria
Brief 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.
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.
Interventions
DRUGsteroids 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
DRUGsteroids
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
A. Manzoni Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline. | Every month for the first six months, then six months |
Secondary
| Measure | Time frame |
|---|---|
| evolution of proteinuria over time | every months for the first six months and then every six months |
| safety | every months for the first six months and then every six months |
Countries
Italy, Switzerland
Outcome results
None listed