Steroids and Azathioprine in Advanced IgAN

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Some years ago the investigators designed a randomised trial to prospectively evaluate whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine <=2.0 mg/dl.

In order to test the efficacy of the combination of steroids with azathioprine at various degree of renal function deterioration by extending the trial to patients with more advanced disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal biopsy. Treatment will last one year: 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, then 0.2 mg/kg every other day for further 6 months. The primary outcome was renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes were proteinuria over time and the number and types of adverse events in the two groups assessed every month for the first six months, every two months from the 6th to the 12th month and every three months thereafter. The planned duration of follow up is five years.

• Phase: Phase 3
• 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:

• Serum creatinine higher or equal to 2.0 mg/dl

• Proteinuria higher or equal to 1g/24g for at least three months

• No time limits for renal biopsy

Exclusion Criteria:

• Steroids and/or cytotoxic drugs (used for more than three months) in the previous three years

• Contraindications to steroids or azathioprine

• Diabetes

• Severe hypertension (diastolic blood pressure > 120 mmHg)

• Liver disease

• Infections

• Active peptic-ulcer disease

• Malignancies

• Pregnancy

• Secondary IgAN