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Completed

NCT Number: NCT02239016

Screening Patients With Sickle Cell Disease for Kidney Damage

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University (Children's Healthcare of Atlanta Pediatric Hospital), Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of progression of microalbuminuria.

    Time frame: Baseline through 36 months

Secondary outcomes

  1. Evaluation of novel urinary biomarkers.

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2009
Primary completion
2019
Study completion
2020
First posted
Sep 12, 2014
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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