"Steroids and Azathioprine Versus Steroids Alone in IgAN"

IGA Nephropathy Clinical Trial

Official title:

Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755859
• Other study ID #: IgANSTAZA
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: September 18, 2008
• Start date: May 1998
• Est. completion date: September 2007

Study information

• Verified date: August 2008
• Source: A. Manzoni Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: September 2007
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Hospital "S.Marta e S.Venera",	Acireale	CT
Italy	Hospital "Spedali Civili"	Brescia
Italy	"G. Brotzu" Hospital	Cagliari
Italy	Hospital "Cannizzaro"	Catania
Italy	Hospital "Uboldo"	Cernusco sul Naviglio	MI
Italy	Hospital "S.Anna"	Como	CO
Italy	Hospital "Istituti Ospitalieri"	Cremona	CR
Italy	Hospital of Desio	Desio	MI
Italy	Hospital "Careggi"	Firenze
Italy	Hospital of University	Foggia
Italy	Department of Nephrology and Dialysis, A. Manzoni Hospital	Lecco	LC
Italy	Hospital "Maggiore"	Lodi	LO
Italy	Hospital "C. Poma"	Mantova
Italy	Hospital "Maggiore" IRCCS	Milano	MI
Italy	Hospital of Montichiari	Montichiari	Brescia
Italy	Hospital "S. Francesco"	Nuoro
Italy	Hospital "A.Segni"	Ozieri	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 "Bolognini"	Seriate	BG
Italy	Hospital of Sondrio	Sondrio
Italy	Hospital "S.Vincenzo"	Taormina	CT
Italy	CMID	Torino
Italy	Hospital "Belcolle"	Viterbo
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
A. Manzoni Hospital

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.		Every month for the first six months, then six months	Yes
Secondary	evolution of proteinuria over time		every months for the first six months and then every six months	No
Secondary	safety		every months for the first six months and then every six months	Yes