Steroids and Azathioprine in Advanced IgAN

NCT01392833 | Completed Phase 3

• 1 other identifier: IgAzaIRC
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

IgA Nephropathy; Chronic Kidney Disease

Keywords

iga nephropathy; chronic kidney disease; proteinuria; steroids; azathioprine

Outcome Measures

Primary Outcomes (1)

• renal survival

  time to a 50% increase in serum creatinine from baseline

  five years

Secondary Outcomes (2)

• proteinuria

  at six month and during follow up

• adverese events (possible treatment related)

  5 years

Study Arms (2)

steroids

ACTIVE COMPARATOR

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; Drug: prednisone

steroids plus azathioprine

EXPERIMENTAL

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; Drug: azathioprine; Drug: prednisone

Interventions

methylprednisolone DRUG

intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5

Also known as: solumedrol

steroids; steroids plus azathioprine

azathioprine DRUG

azathioprine 1.5 mg/kg/day for six months followed by azathioprine 50 mg/day for a further six months.

Also known as: azatioprina

steroids plus azathioprine

prednisone DRUG

prednisone 0.5 mg/kg every other day followed by prednisone 0.2 mg/kg every other day for a further six months.

Also known as: deltacortene

steroids; steroids plus azathioprine

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A. Manzoni Hospital: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA; Renal Insufficiency, Chronic; Proteinuria

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Azathioprine; Adenosine Triphosphate; Prednisone; deltacortene

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Adenine Nucleotides; Purine Nucleotides; Nucleotides; Ribonucleotides; Pregnadienediols

Study Officials

• claudio pozzi, md

  A. Manzoni Hospital, ospedale G. bassini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 13, 2011
• Study Start: December 1, 1999
• Primary Completion: November 1, 2006
• Study Completion: January 1, 2008
• Last Updated: July 13, 2011

Record last verified: 2011-03