"Steroids and Azathioprine Versus Steroids Alone in IgAN"
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| ClinicalTrials.gov Identifier: NCT00755859 |
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Recruitment Status :
Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
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Sponsor:
A. Manzoni Hospital
Information provided by:
A. Manzoni Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| IGA Nephropathy | Drug: steroids plus azathioprine Drug: steroids | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 206 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. |
| Study Start Date : | May 1998 |
| Actual Primary Completion Date : | December 2004 |
| Actual Study Completion Date : | September 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Six month steroid course plus azathioprine
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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:
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Active Comparator: 2
six month steroid course
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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:
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Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ]
- safety [ Time Frame: every months for the first six months and then every six months ]
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| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755859
Locations
Show 28 study locations
Sponsors and Collaborators
A. Manzoni Hospital
Investigators
| 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 |
Publications:
| Responsible Party: | Claudio Pozzi, A. Manzoni Hospital, Lecco, Italy |
| ClinicalTrials.gov Identifier: | NCT00755859 |
| Other Study ID Numbers: |
IgANSTAZA |
| First Posted: | September 19, 2008 Key Record Dates |
| Last Update Posted: | September 19, 2008 |
| Last Verified: | August 2008 |
Keywords provided by A. Manzoni Hospital:
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IgA nephropathy steroids azathioprine chronic kidney disease progression proteinuria |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Prednisone Methylprednisolone Hemisuccinate Methylprednisolone Acetate Methylprednisolone Prednisolone Prednisolone acetate Azathioprine Prednisolone hemisuccinate |
Prednisolone phosphate Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Neuroprotective Agents |