"Steroids and Azathioprine Versus Steroids Alone in IgAN"
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.
1 other identifier
interventional
206
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 1998
Longer than P75 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedSeptember 19, 2008
August 1, 2008
6.6 years
September 18, 2008
September 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
evolution of proteinuria over time
every months for the first six months and then every six months
safety
every months for the first six months and then every six months
Study Arms (2)
1
EXPERIMENTALSix month steroid course plus azathioprine
2
ACTIVE COMPARATORsix month steroid course
Interventions
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
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
Eligibility Criteria
You may qualify if:
- biopsy proven IgA nephropathy
- creatinine ≤ 2.0 mg/dl for at least three months
- proteinuria ≥ 1.0 g/day for at least three months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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, 22100, 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, 23900, 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
Related 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.
PMID: 10630693BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
May 1, 1998
Primary Completion
December 1, 2004
Study Completion
September 1, 2007
Last Updated
September 19, 2008
Record last verified: 2008-08