"Steroids and Azathioprine Versus Steroids Alone in IgAN"

This study has been completed.
Sponsor:
Information provided by:
A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT00755859
First received: September 18, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
IGA Nephropathy
Drug: steroids plus azathioprine
Drug: steroids
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by A. Manzoni Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: No ]
  • safety [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: May 1998
Study Completion Date: September 2007
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755859

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

Publications:
Responsible Party: Claudio Pozzi, A. Manzoni Hospital, Lecco, Italy
ClinicalTrials.gov Identifier: NCT00755859     History of Changes
Other Study ID Numbers: IgANSTAZA
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by A. Manzoni Hospital:
IgA nephropathy
steroids
azathioprine
chronic kidney disease progression
proteinuria

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014