"Steroids and Azathioprine Versus Steroids Alone in IgAN"

A. Manzoni Hospital

Status and phase: Completed; Phase 4

Conditions: IGA Nephropathy

Treatments: Drug: steroids plus azathioprine; Drug: steroids

Study type: Interventional

Funder types: Other

Identifiers

NCT00755859

IgANSTAZA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

1

Experimental group

Description:

Six month steroid course plus azathioprine

Treatment:

Drug: steroids plus azathioprine

2

Active Comparator group

Description:

six month steroid course

Treatment:

Drug: steroids