"Steroids and Azathioprine Versus Steroids Alone in IgAN"

Study Description

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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

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.

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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: solumedrol; deltacortene; azatioprina
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: solumedrol; deltacortene

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ]
2. safety [ Time Frame: every months for the first six months and then every six months ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 70 Years (Child, Adult, Senior)
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

Contacts and Locations

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Locations

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

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

More Information

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Publications:

Locatelli F, Pozzi C, Del Vecchio L, Andrulli S, Pani A, Fogazzi G, Altieri P, Ponticelli C. Combined treatment with steroids and azathioprine in IgA nephropathy: design of a prospective randomised multicentre trial. J Nephrol. 1999 Sep-Oct;12(5):308-11.

Responsible Party:	Claudio Pozzi, A. Manzoni Hospital, Lecco, Italy
ClinicalTrials.gov Identifier:	NCT00755859 History of Changes
Other Study ID Numbers:	IgANSTAZA
First Posted:	September 19, 2008
Last Update Posted:	September 19, 2008
Last Verified:	August 2008

Keywords provided by A. Manzoni Hospital:

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

Additional relevant MeSH terms:

Kidney Diseases; Glomerulonephritis, IGA; Urologic Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Prednisolone acetate; Methylprednisolone acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisone; Prednisolone hemisuccinate; Prednisolone phosphate	Azathioprine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic