Status:
COMPLETED
"Steroids and Azathioprine Versus Steroids Alone in IgAN"
Lead Sponsor:
A. Manzoni Hospital
Conditions:
IGA Nephropathy
Eligibility:
All Genders
16-70 years
Phase:
PHASE4
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 con...
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 5...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00755859
Start Date
May 1 1998
End Date
September 1 2007
Last Update
September 19 2008
Active Locations (28)
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1
Hospital "Bolognini"
Seriate, BG, Italy
2
Hospital "Spedali Civili"
Brescia, Brescia, Italy
3
Hospital of Montichiari
Montichiari, Brescia, Italy
4
"G. Brotzu" Hospital
Cagliari, Cagliari, Italy