Screening Patients With Sickle Cell Disease for Kidney Damage

Children's Hospital Medical Center, Cincinnati320 enrolled

Overview

This study aims to study the temporal course of sickle nephropathy and assess novel biomarkers that can predict patients prone to nephropathy.

Sickle cell disease causes kidney damage that gets worse with increasing age, leading to chronic kidney disease and kidney failure in nearly one third of patients with sickle cell disease. Some patients develop kidney damage at a young age and others show mild kidney damage at older ages. We do not know the natural progression of kidney damage in sickle cell disease patients, nor do we know who is more prone to develop severe kidney damage. Therefore, currently, there are no preventative measures or treatments for sickle cell related kidney disease. The purpose of this research study is to collect data that will help in assessing the progression of kidney damage in sickle cell disease, develop novel urine and blood tests that can predict kidney damage early, and developing treatment ideas for intervention and prevention of kidney damage that eventually leads to kidney failure.

Study Type

OBSERVATIONAL

Enrollment

320

Conditions

Sickle Cell Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Sickle cell disease (i.e. Hgb SS, Hgb SC, Sβ-Thalassemia) * Individuals at baseline/steady state (absence of fever or acute sickle event, defined as vaso-occlusive pain crises, acute chest syndrome, splenic sequestration, stroke, priapism) for three weeks. * Adult Subjects \> 18 years of age: ability to consent to donate blood and/or urine for research purposes only. * Newborn to \< 18 years of age: ability of parent/legal guardian to consent for peripheral blood and/or urine samples to be obtained for research purposes only. Exclusion Criteria: * Hematologic malignancy * Patients that either do not have the ability to undergo the informed consent process or whose parent/legal guardian does not have the ability to undergo the informed consent process

Locations (4)

Emory University (Children's Healthcare of Atlanta Pediatric Hospital)

Atlanta, Georgia, United States

Univeristy of Louisville (Kosair Children's Hospital)

Louisville, Kentucky, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Akron Childen's Hospital

Akron, Ohio, United States

Outcomes

Primary Outcomes

Rate of progression of microalbuminuria.

Time frame: Baseline through 36 months

Secondary Outcomes

Evaluation of novel urinary biomarkers.

Time frame: baseline, year 1, year 2 and year 3

Data from ClinicalTrials.gov

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