"Steroids and Azathioprine Versus Steroids Alone in IgAN"
- Conditions
- IGA Nephropathy
- Interventions
- Drug: steroids
- Registration Number
- NCT00755859
- Lead Sponsor
- A. Manzoni Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- biopsy proven IgA nephropathy
- creatinine ≤ 2.0 mg/dl for at least three months
- proteinuria ≥ 1.0 g/day for at least three months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 steroids plus azathioprine Six month steroid course plus azathioprine 2 steroids six month steroid course
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (28)
Hospital "Bolognini"
🇮🇹Seriate, BG, Italy
Hospital "Careggi"
🇮🇹Firenze, Italy
Hospital "Istituti Ospitalieri"
🇮🇹Cremona, CR, Italy
Hospital "S.Vincenzo"
🇮🇹Taormina, CT, Italy
Department of Nephrology and Dialysis, A. Manzoni Hospital
🇮🇹Lecco, LC, Italy
Hospital "Maggiore" IRCCS
🇮🇹Milano, MI, Italy
Hospital "A.Segni"
🇮🇹Ozieri, Nuoro, Italy
Hospital "Uboldo"
🇮🇹Cernusco sul Naviglio, MI, Italy
Hospital of University
🇮🇹Foggia, Italy
"G. Brotzu" Hospital
🇮🇹Cagliari, Italy
Hospital "C. Poma"
🇮🇹Mantova, Italy
CMID
🇮🇹Torino, Italy
Hospital of Montichiari
🇮🇹Montichiari, Brescia, Italy
Hospital "S.Anna"
🇮🇹Como, CO, Italy
Hospital "Cannizzaro"
🇮🇹Catania, Italy
Hospital "V. Cervello"
🇮🇹Palermo, Italy
CNR-IBIM
🇮🇹Reggio Calabria, Italy
Hospital "S. Maria Nuova"
🇮🇹Reggio Emilia, Italy
Hospital "Belcolle"
🇮🇹Viterbo, Italy
Hospital "Maggiore"
🇮🇹Lodi, LO, Italy
Hospital "S. Francesco"
🇮🇹Nuoro, Italy
University Hospital
🇮🇹Parma, Italy
Fondazione Maugeri" IRCCS
🇮🇹Pavia, Italy
Hospital of Desio
🇮🇹Desio, MI, Italy
Hospital "S.Marta e S.Venera",
🇮🇹Acireale, CT, Italy
Hospital "Spedali Civili"
🇮🇹Brescia, Italy
Hospital of Sondrio
🇮🇹Sondrio, Italy
Inselspital
🇨🇭Bern, Switzerland