Screening Patients With Sickle Cell Disease for Kidney Damage

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02239016

Enrollment

320

Registered

2014-09-12

Start date

2009-04-30

Completion date

2020-07-29

Last updated

2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease, Hgb SS, Hgb SC, Sβ-Thalassemia

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of progression of microalbuminuria.	Baseline through 36 months

Secondary

Measure	Time frame
Evaluation of novel urinary biomarkers.	baseline, year 1, year 2 and year 3

Countries

United States

Outcome results