"Steroids and Azathioprine Versus Steroids Alone in IgAN"

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A. Manzoni Hospital
• Treatments: Azathioprine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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