"Steroids and Azathioprine Versus Steroids Alone in IgAN"
Launched by A. MANZONI HOSPITAL · Sep 18, 2008
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
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 remissio...
Gender
ALL
Eligibility 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
About A. Manzoni Hospital
Manzoni Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence, the hospital integrates state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals to conduct rigorous scientific studies. By collaborating with academic institutions and industry partners, Manzoni Hospital aims to contribute to the development of new therapies and treatment protocols, ultimately enhancing the quality of life for patients. The hospital prioritizes patient safety and ethical standards, ensuring a transparent and supportive environment for all participants in its clinical research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bern, , Switzerland
Seriate, Bg, Italy
Montichiari, Brescia, Italy
Como, Co, Italy
Cremona, Cr, Italy
Acireale, Ct, Italy
Taormina, Ct, Italy
Lecco, Lc, Italy
Lodi, Lo, Italy
Cernusco Sul Naviglio, Mi, Italy
Desio, Mi, Italy
Milano, Mi, Italy
Ozieri, Nuoro, Italy
Brescia, , Italy
Cagliari, , Italy
Catania, , Italy
Firenze, , Italy
Foggia, , Italy
Mantova, , Italy
Nuoro, , Italy
Palermo, , Italy
Parma, , Italy
Pavia, , Italy
Reggio Calabria, , Italy
Reggio Emilia, , Italy
Sondrio, , Italy
Torino, , Italy
Viterbo, , Italy
Patients applied
Trial Officials
Claudio Pozzi, MD
Principal Investigator
A Manzoni Hospital, Lecco, Italy
Francesco Locatelli, MD
Study Chair
A Manzoni Hospital, Lecco, Italy
Simeone Andrulli, MD
Study Director
A Manzoni Hospital, Lecco, Italy
Antonello Pani, MD
Study Director
Hospital "G. Brotzu", Cagliari, Italy
Paolo Altieri, MD
Study Director
Hospital "G. Brotzu", Cagliari, Italy
Gian B Fogazzi, MD
Study Director
Hospital "Maggiore" IRCCS, Milan, Italy
Claudio Ponticelli, MD
Study Director
Hospital "Maggiore" IRCCS, Milan, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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