"Steroids and Azathioprine Versus Steroids Alone in IgAN"
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
IGA Nephropathy |
Drug: steroids plus azathioprine Drug: steroids |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. |
- progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline. [ Time Frame: Every month for the first six months, then six months ] [ Designated as safety issue: Yes ]
- evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: No ]
- safety [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: Yes ]
| Enrollment: | 206 |
| Study Start Date: | May 1998 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Six month steroid course plus azathioprine
|
Drug: steroids plus azathioprine
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 plus azathioprine 1.5 mg/kg/day for six months
Other Names:
|
|
Active Comparator: 2
six month steroid course
|
Drug: steroids
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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00755859
| Italy | |
| Hospital "Bolognini" | |
| Seriate, BG, Italy | |
| Hospital of Montichiari | |
| Montichiari, Brescia, Italy | |
| Hospital "S.Anna" | |
| Como, CO, Italy, 22100 | |
| Hospital "Istituti Ospitalieri" | |
| Cremona, CR, Italy | |
| Hospital "S.Marta e S.Venera", | |
| Acireale, CT, Italy | |
| Hospital "S.Vincenzo" | |
| Taormina, CT, Italy | |
| Department of Nephrology and Dialysis, A. Manzoni Hospital | |
| Lecco, LC, Italy, 23900 | |
| Hospital "Maggiore" | |
| Lodi, LO, Italy | |
| Hospital "Uboldo" | |
| Cernusco sul Naviglio, MI, Italy | |
| Hospital of Desio | |
| Desio, MI, Italy | |
| Hospital "Maggiore" IRCCS | |
| Milano, MI, Italy | |
| Hospital "A.Segni" | |
| Ozieri, Nuoro, Italy | |
| Hospital "Spedali Civili" | |
| Brescia, Italy | |
| "G. Brotzu" Hospital | |
| Cagliari, Italy | |
| Hospital "Cannizzaro" | |
| Catania, Italy | |
| Hospital "Careggi" | |
| Firenze, Italy | |
| Hospital of University | |
| Foggia, Italy | |
| Hospital "C. Poma" | |
| Mantova, Italy | |
| Hospital "S. Francesco" | |
| Nuoro, Italy | |
| Hospital "V. Cervello" | |
| Palermo, Italy | |
| University Hospital | |
| Parma, Italy | |
| Fondazione Maugeri" IRCCS | |
| Pavia, Italy | |
| CNR-IBIM | |
| Reggio Calabria, Italy | |
| Hospital "S. Maria Nuova" | |
| Reggio Emilia, Italy | |
| Hospital of Sondrio | |
| Sondrio, Italy | |
| CMID | |
| Torino, Italy | |
| Hospital "Belcolle" | |
| Viterbo, Italy | |
| Switzerland | |
| Inselspital | |
| Bern, Switzerland | |
| Principal Investigator: | Claudio Pozzi, MD | A Manzoni Hospital, Lecco, Italy | |
| Study Chair: | Francesco Locatelli, MD | A Manzoni Hospital, Lecco, Italy | |
| Study Director: | Simeone Andrulli, MD | A Manzoni Hospital, Lecco, Italy | |
| Study Director: | Antonello Pani, MD | Hospital "G. Brotzu", Cagliari, Italy | |
| Study Director: | Paolo Altieri, MD | Hospital "G. Brotzu", Cagliari, Italy | |
| Study Director: | Gian B Fogazzi, MD | Hospital "Maggiore" IRCCS, Milan, Italy | |
| Study Director: | Claudio Ponticelli, MD | Hospital "Maggiore" IRCCS, Milan, Italy |
More Information
Publications:
| Responsible Party: | Claudio Pozzi, A. Manzoni Hospital, Lecco, Italy |
| ClinicalTrials.gov Identifier: | NCT00755859 History of Changes |
| Other Study ID Numbers: | IgANSTAZA |
| Study First Received: | September 18, 2008 |
| Last Updated: | September 18, 2008 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by A. Manzoni Hospital:
|
IgA nephropathy steroids azathioprine chronic kidney disease progression proteinuria |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Autoimmune Diseases Glomerulonephritis Immune System Diseases Nephritis Urologic Diseases Azathioprine Methylprednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate |
Prednisone Anti-Inflammatory Agents Antiemetics Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antineoplastic Agents, Hormonal Antirheumatic Agents Autonomic Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunologic Factors |
ClinicalTrials.gov processed this record on February 25, 2015