NCT02529722

Completed

Biomarkers for the Progression of IgA Nephropathy

Istanbul University Source

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Other study identifiers

Sponsor study identifier

2907

Study Type

observational

Actual enrollment (reported)

120

Locations

1 country

Sites

1

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2015

Actual (reported)

Study Completion

April 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 120 participants
Study completion date: April 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)
Study Completion
April 2015
Actual (reported)
First Submitted
August 7, 2015
Actual (reported)
First Posted
August 20, 2015
Actual (reported)

Last Updated: August 20, 2015
Status Verified: August 2015
Last Update Submitted: August 19, 2015

Conditions

Glomerular Diseases IgA Nephropathy

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

Age16 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability 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)

Sponsors & Collaborators

Istanbul University
Otherlead

Study Sites (1)

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, 34093, Turkey (Türkiye)

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Yasar Caliskan, MD
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 2Withdrawn

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.

Contact the study team to confirm eligibility.

Primary Completion

January 2015

Actual (reported)

Study Completion

April 2015

Actual (reported)

Last Updated

August 20, 2015

Record last verified: 2015-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02529722
Data provider: ClinicalTrials.gov
Source updated: 2015-08-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:48 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations