Sickle Cell Kidney Biorepository
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
Kidney disease is a major cause of illness and death in people with sickle cell disease and sickle cell trait. Despite these concerning facts, we do not (1) have an in-depth understanding of how kidney disease starts in sickle cell disease and sickle cell trait, (2) have detailed insights into why kidney disease is worse in people with sickle cell disease and sickle cell trait, (3) have management options that are tailored to treating or preventing kidney disease in people with sickle cell disease or sickle cell trait.
The SCeK Biorepository is a specialized, secure repository designed for the collection of blood and urine samples from people with sickle cell disease and sickle cell trait. These samples are connected to detailed medical records, with the sole purpose of allowing researchers to better understand how kidney disease starts and progresses in people with the sickle cell gene. By studying these stored samples (using new tests) together with health information, researchers can find better early warning signs of kidney injury and develop better ways to protect kidney health in people with sickle cell disease and sickle cell trait.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age over 18 years,
Estimated glomerular filtration rate greater than or equal to 15 mL/min,
Presence of any hemoglobinopathy (will need to be confirmed by hemoglobin electrophoresis or genetic testing),
Controls (absence of hemoglobinopathy) will be subject to review and only selected if demographics are identical to a currently enrolled participant with a hemoglobinopathy.
Disqualifiers
Age 66 years or older,
Estimated glomerular filtration rate less than 15 mL/min or on dialysis,
Active pregnancy (may be enrolled 4 weeks or more after delivery),
Active sickle cell pain episode requiring hospitalization or emergency room visit or pain infusion clinic visit (may be enrolled 2 weeks or more after resolution of severe pain),
Trial population
Participants include all eligible adults who are able to provide samples at the primary study site(s). Health data and surveys can be completed electronically.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Kidney function decline
Mean change in the estimated glomerular filtration rate per year
Time frame
10 years2
Albuminuria
Mean change in the urine albumin-to-creatinine ratio per year
Time frame
10 yearsSecondary outcomes
1
Mortality
Time to death over follow up period
Time frame
10 years2
Hospitalization rates
Frequency of hospitalizations and emergency room visits over follow up
Time frame
10 years3
Cardiovascular outcomes
Incident left ventricular hypertrophy, diastolic dysfunction, heart failure, pulmonary hypertension, or stroke.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov