Biomarkers for the Progression of IgA Nephropathy

NCT02529722 | Completed

• 1 other identifier: 2907
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per million age-related population in adults and 3-5/new cases/year/per million age-related population in children and progresses to need of renal replacement treatment in 5-15% at 10 years and in about 20% at 20 years. The variability of the clinical course anticipates different treatment options. There is an absolute need of validated biomarkers to predict risk of progression and indication for treatment at early stages, when lesions can be reversible. This study aimed to evaluate IgAN progression and its histological and clinical correlates.

Conditions

IgA Nephropathy; Glomerular Diseases

Outcome Measures

Primary Outcomes (1)

• Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline

  36 months

Secondary Outcomes (1)

• Resistance of proteinuria

  36 months

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with the diagnosis of biopsy confirmed IgA nephropathy

You may qualify if:

• Patients with biopsy-proven IgA nephropathy (defined by standard criteria)
• Patients at all ages will be included regardless of treatment given
• A renal biopsy available for reviewing must include 8 or more glomeruli.
• At least 3 measurements of blood pressure, serum creatinine and proteinuria have to be performed.
• The first measurement should be within 3 months of the date of renal biopsy and the last at the end of the follow-up.
• Patients must comply with the following criteria
• have a follow-up longer than 1 year
• or having progressed to end-stage renal disease regardless of the duration of follow-up.
• Patients who have received antihypertensive or immunosuppressive medication will be included as well.

You may not qualify if:

• Diabetes at the time of first kidney biopsy.
• Solid organ (other than kidney) or bone marrow transplant at the time of biopsy.
• Other pre-existing parenchymal kidney disease on first kidney biopsy, determined by the pathology examination.
• Diagnosis of any of the following diseases from the time of biopsy to the time of enrollment: Systemic lupus erythematosus, HIV infection, active malignancy, except for non-melanoma skin cancer, active hepatitis B or C infection, defined as positive viral load
• Patients with life expectancy \< 6 months
• Patients who are unwilling or unable to consent.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

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

Study Officials

• Yasar Caliskan, MD

  Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 20, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

TU (1)