"Steroids and Azathioprine Versus Steroids Alone in IgAN"

NCT ID: NCT00755859

Last Updated: 2008-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2007-09-30

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.

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.

Conditions

IGA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Six month steroid course plus azathioprine

Group Type: EXPERIMENTAL

steroids plus azathioprine

Intervention Type: DRUG

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

2

six month steroid course

Group Type: ACTIVE_COMPARATOR

steroids

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

solumedrol; deltacortene; azatioprina; solumedrol; deltacortene

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A. Manzoni Hospital

OTHER

Sponsor Role: lead

Responsible Party

A. Manzoni Hospital, Lecco, Italy

Principal Investigators

Claudio Pozzi, MD

Role: PRINCIPAL_INVESTIGATOR

A Manzoni Hospital, Lecco, Italy

Francesco Locatelli, MD

Role: STUDY_CHAIR

A Manzoni Hospital, Lecco, Italy

Simeone Andrulli, MD

Role: STUDY_DIRECTOR

A Manzoni Hospital, Lecco, Italy

Antonello Pani, MD

Role: STUDY_DIRECTOR

Hospital "G. Brotzu", Cagliari, Italy

Paolo Altieri, MD

Role: STUDY_DIRECTOR

Hospital "G. Brotzu", Cagliari, Italy

Gian B Fogazzi, MD

Role: STUDY_DIRECTOR

Hospital "Maggiore" IRCCS, Milan, Italy

Claudio Ponticelli, MD

Role: STUDY_DIRECTOR

Hospital "Maggiore" IRCCS, Milan, Italy

Locations

Hospital "Bolognini"

Seriate, BG, Italy

Hospital "Spedali Civili"

Brescia, Brescia, Italy

Hospital of Montichiari

Montichiari, Brescia, Italy

"G. Brotzu" Hospital

Cagliari, Cagliari, Italy

Hospital "Cannizzaro"

Catania, Catania, Italy

Hospital "S.Anna"

Como, CO, Italy

Hospital "Istituti Ospitalieri"

Cremona, CR, Italy

Hospital "S.Marta e S.Venera",

Acireale, CT, Italy

Hospital "S.Vincenzo"

Taormina, CT, Italy

Hospital "Careggi"

Florence, Firenze, Italy

Hospital of University

Foggia, Foggia, Italy

Department of Nephrology and Dialysis, A. Manzoni Hospital

Lecco, LC, Italy

Hospital "Maggiore"

Lodi, LO, Italy

Hospital "C. Poma"

Mantova, Mantova, Italy

Hospital "Uboldo"

Cernusco sul Naviglio, MI, Italy

Hospital of Desio

Desio, MI, Italy

Hospital "Maggiore" IRCCS

Milan, MI, Italy

Hospital "S. Francesco"

Nuoro, Nuoro, Italy

Hospital "A.Segni"

Ozieri, Nuoro, Italy

Hospital "V. Cervello"

Palermo, Palermo, Italy

University Hospital

Parma, Parma, Italy

Fondazione Maugeri" IRCCS

Pavia, Pavia, Italy

CNR-IBIM

Reggio Calabria, Reggio Calabria, Italy

Hospital "S. Maria Nuova"

Reggio Emilia, Reggio Emilia, Italy

Hospital of Sondrio

Sondrio, Sondrio, Italy

CMID

Torino, Torino, Italy

Hospital "Belcolle"

Viterbo, Viterbo, Italy

Inselspital

Bern, , Switzerland

Countries

Italy; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 10630693 (View on PubMed)

Other Identifiers

IgANSTAZA

Identifier Type: -

Identifier Source: org_study_id