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Screening Patients With Sickle Cell Disease for Kidney Damage

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ClinicalTrials.gov Identifier: NCT02239016
Recruitment Status : Active, not recruiting
First Posted : September 12, 2014
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease
Sickle Cell Disease

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Patients With Sickle Cell Disease for Kidney Damage
Study Start Date : April 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of progression of microalbuminuria. [ Time Frame: Baseline through 36 months ]

Secondary Outcome Measures :
  1. Evaluation of novel urinary biomarkers. [ Time Frame: baseline, year 1, year 2 and year 3 ]

Biospecimen Retention:   Samples With DNA
Urine, whole blood and serum


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell clinics at various universities and hospitals.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239016


Locations
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United States, Georgia
Emory University (Children's Healthcare of Atlanta Pediatric Hospital)
Atlanta, Georgia, United States, 30322
United States, Kentucky
Univeristy of Louisville (Kosair Children's Hospital)
Louisville, Kentucky, United States, 40202
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
United States, Ohio
Akron Childen's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Punam Malik, MD Children's Hospital Medical Center, Cincinnati

Publications of Results:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02239016     History of Changes
Other Study ID Numbers: 2009-0026
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Sickle cell disease
Hgb SS
Hgb SC
Sβ-Thalassemia

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn