Screening Patients With Sickle Cell Disease for Kidney Damage

Sickle Cell Disease Clinical Trial

Official title:

Screening Patients With Sickle Cell Disease for Kidney Damage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239016
• Other study ID #: 2009-0026
• Status: Completed
• Start date: April 2009
• Est. completion date: July 29, 2020

Study information

• Verified date: March 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Sickle cell disease (i.e. Hgb SS, Hgb SC, Sß-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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Akron Childen's Hospital	Akron	Ohio
United States	Emory University (Children's Healthcare of Atlanta Pediatric Hospital)	Atlanta	Georgia
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	Univeristy of Louisville (Kosair Children's Hospital)	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sundaram N, Bennett M, Wilhelm J, Kim MO, Atweh G, Devarajan P, Malik P. Biomarkers for early detection of sickle nephropathy. Am J Hematol. 2011 Jul;86(7):559-66. doi: 10.1002/ajh.22045. Epub 2011 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of progression of microalbuminuria.		Baseline through 36 months
Secondary	Evaluation of novel urinary biomarkers.		baseline, year 1, year 2 and year 3