IGA NephropathyPhase 4NCT00755859
"Steroids and Azathioprine Versus Steroids Alone in IgAN"
A Phase 4 study testing steroids plus azathioprine and steroids in people with IGA Nephropathy, run by A. Manzoni Hospital at 28 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- steroids plus azathioprine and steroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 28 sitesin 2 countries
- Study dates
- May 1998to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- biopsy proven IgA nephropathy
- creatinine ≤ 2.0 mg/dl for at least three months
- proteinuria ≥ 1.0 g/day for at least three months
Who cannot join
- 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
Show all 10Show fewer
- malignancies
- active peptic-ulcer disease
- pregnancy
- viral hepatitis or other infections
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
Italy27 sites
Hospital "S.Marta e S.Venera",
Acireale, CT
Hospital "Spedali Civili"
Brescia, Brescia
"G. Brotzu" Hospital
Cagliari, Cagliari
Hospital "Cannizzaro"
Catania, Catania
Hospital "Uboldo"
Cernusco sul Naviglio, MI
Hospital "S.Anna"
Como, CO, 22100
Hospital "Istituti Ospitalieri"
Cremona, CR
Hospital of Desio
Desio, MI
Hospital "Careggi"
Florence, Firenze
Hospital of University
Foggia, Foggia
Department of Nephrology and Dialysis, A. Manzoni Hospital
Lecco, LC, 23900
Hospital "Maggiore"
Lodi, LO
Hospital "C. Poma"
Mantua, Mantova
Hospital "Maggiore" IRCCS
Milan, MI
Hospital of Montichiari
Montichiari, Brescia
Hospital "S. Francesco"
Nuoro, Nuoro
Hospital "A.Segni"
Ozieri, Nuoro
Hospital "V. Cervello"
Palermo, Palermo
University Hospital
Parma, Parma
Fondazione Maugeri" IRCCS
Pavia, Pavia
CNR-IBIM
Reggio Calabria, Reggio Calabria
Hospital "S. Maria Nuova"
Reggio Emilia, Reggio Emilia
Hospital "Bolognini"
Seriate, BG
Hospital of Sondrio
Sondrio, Sondrio
Hospital "S.Vincenzo"
Taormina, CT
CMID
Torino, Torino
Hospital "Belcolle"
Viterbo, Viterbo
About this study
Official title: Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.
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.
Read the 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
- Being tested
- steroids plus azathioprine, steroids
- Keywords
- IgA nephropathy, steroids, azathioprine, chronic kidney disease progression, proteinuria
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroids plus azathioprineDrug
Also called solumedrol, deltacortene, azatioprina
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
steroidsDrug
Also called solumedrol, deltacortene
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Six month steroid course plus azathioprine Receives: Drug: steroids plus azathioprine |
| 2 | Active comparator | six month steroid course Receives: Drug: steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.
Measured: Every month for the first six months, then six months
Secondary outcomes (2)
evolution of proteinuria over time
Measured: every months for the first six months and then every six months
safety
Measured: every months for the first six months and then every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startMay 1998
- Primary completionDec 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IGA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Manzoni Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Claudio Pozzi, MD, Principal investigator, A Manzoni Hospital, Lecco, ItalyFrancesco Locatelli, MD, Study chair, A Manzoni Hospital, Lecco, ItalySimeone Andrulli, MD, Study director, A Manzoni Hospital, Lecco, ItalyAntonello Pani, MD, Study director, Hospital "G. Brotzu", Cagliari, ItalyPaolo Altieri, MD, Study director, Hospital "G. Brotzu", Cagliari, ItalyGian B Fogazzi, MD, Study director, Hospital "Maggiore" IRCCS, Milan, ItalyClaudio Ponticelli, MD, Study director, Hospital "Maggiore" IRCCS, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755859
- Sponsor's protocol ID
- IgANSTAZA
- Status last verified
- Aug 2008
- First submitted
- 18 Sep 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 10630693
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00755859
- Acronym / sponsor ID
- IgANSTAZA
- Conditions
- IGA Nephropathy
- Keywords
- IgA nephropathy, steroids, azathioprine, chronic kidney disease progression, proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- A. Manzoni HospitalUniversity, hospital or other
- Study start
- May 1998
- Primary completion
- Dec 2004 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: steroids plus azathioprineSix month steroid course plus azathioprine |
| 2 | Active comparator | Drug: steroidssix month steroid course |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- biopsy proven IgA nephropathy
- creatinine ≤ 2.0 mg/dl for at least three months
- proteinuria ≥ 1.0 g/day for at least three months
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroids plus azathioprineAlso: solumedrol, deltacortene, azatioprinamethylprednisolone 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 | Drug | 1 |
| steroidsAlso: solumedrol, deltacortenemethylprednisolone 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 | Drug | 2 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
- Background: PubMed 10630693Locatelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Pozzi, MD principal investigator
A Manzoni Hospital, Lecco, Italy
Francesco Locatelli, MD study chair
A Manzoni Hospital, Lecco, Italy
Simeone Andrulli, MD study director
A Manzoni Hospital, Lecco, Italy
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing steroids plus azathioprine and steroids in people with IGA Nephropathy, run by A. Manzoni Hospital at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2008.