"Steroids and Azathioprine Versus Steroids Alone in IgAN"
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ClinicalTrials.gov Identifier: NCT00755859 |
Recruitment Status :
Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
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Condition or disease | Intervention/treatment | Phase |
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IGA Nephropathy | Drug: steroids plus azathioprine Drug: steroids | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
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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- 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 ]
- 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 |
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

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

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 |
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 |
IgA nephropathy steroids azathioprine chronic kidney disease progression proteinuria |
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 |