Steroids and Azathioprine in Advanced IgAN

This study has been completed.
Sponsor:
Information provided by:
A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01392833
First received: July 5, 2011
Last updated: July 12, 2011
Last verified: March 2011
  Purpose

Some years ago the investigators designed a randomised trial to prospectively evaluate whether adding low-dose azathioprine (1.5 mg/kg/day for six months) to steroids (methylprednisolone 1 g i.v. for three consecutive days at months 1, 3 and 5, plus oral prednisone 0.5 mg/kg every other day for six months) can improve long-term renal survival in adult IgAN patients with proteinuria higher than 1g/24 hours and plasma creatinine <=2.0 mg/dl.

In order to test the efficacy of the combination of steroids with azathioprine at various degree of renal function deterioration by extending the trial to patients with more advanced disease (serum creatinine higher or equal to 2 mg/dl) without any time limit for renal biopsy. Treatment will last one year: 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, then 0.2 mg/kg every other day for further 6 months. The primary outcome was renal survival (a 50% increase in plasma creatinine from baseline); the secondary outcomes were proteinuria over time and the number and types of adverse events in the two groups assessed every month for the first six months, every two months from the 6th to the 12th month and every three months thereafter. The planned duration of follow up is five years.


Condition Intervention Phase
IgA Nephropathy
Chronic Kidney Disease
Drug: methylprednisolone
Drug: azathioprine
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial

Resource links provided by NLM:


Further study details as provided by A. Manzoni Hospital:

Primary Outcome Measures:
  • renal survival [ Time Frame: five years ] [ Designated as safety issue: No ]
    time to a 50% increase in serum creatinine from baseline


Secondary Outcome Measures:
  • proteinuria [ Time Frame: at six month and during follow up ] [ Designated as safety issue: No ]
    proteinuria changes

  • adverese events (possible treatment related) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: December 1999
Study Completion Date: January 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: steroids
intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5, and oral prednisone 0.5 mg/kg every other day for six months followed by oral prednisone 0.2 mg/kg every other day for a further six months.
Drug: methylprednisolone
intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5
Other Name: solumedrol
Drug: prednisone
prednisone 0.5 mg/kg every other day followed by prednisone 0.2 mg/kg every other day for a further six months.
Other Name: deltacortene
Experimental: steroids plus azathioprine
intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5, and oral prednisone 0.5 mg/kg every other day plus azathioprine 1.5 mg/kg/day for six months followed by oral prednisone 0.2 mg/kg every other day plus azathioprine 50 mg/day for a further six months.
Drug: methylprednisolone
intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5
Other Name: solumedrol
Drug: azathioprine
azathioprine 1.5 mg/kg/day for six months followed by azathioprine 50 mg/day for a further six months.
Other Name: azatioprina
Drug: prednisone
prednisone 0.5 mg/kg every other day followed by prednisone 0.2 mg/kg every other day for a further six months.
Other Name: deltacortene

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serum creatinine higher or equal to 2.0 mg/dl
  • Proteinuria higher or equal to 1g/24g for at least three months
  • No time limits for renal biopsy

Exclusion Criteria:

  • Steroids and/or cytotoxic drugs (used for more than three months) in the previous three years
  • Contraindications to steroids or azathioprine
  • Diabetes
  • Severe hypertension (diastolic blood pressure > 120 mmHg)
  • Liver disease
  • Infections
  • Active peptic-ulcer disease
  • Malignancies
  • Pregnancy
  • Secondary IgAN
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01392833

Sponsors and Collaborators
A. Manzoni Hospital
Investigators
Principal Investigator: claudio pozzi, md A. Manzoni Hospital, ospedale G. bassini
  More Information

No publications provided

Responsible Party: Claudio Pozzi, Ospedale E. Bassini and A. manzoni Hospital
ClinicalTrials.gov Identifier: NCT01392833     History of Changes
Other Study ID Numbers: IgAzaIRC
Study First Received: July 5, 2011
Last Updated: July 12, 2011
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Renal Insufficiency, Chronic
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Nephritis
Renal Insufficiency
Urologic Diseases
Azathioprine
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 23, 2014