Screening Patients With Sickle Cell Disease for Kidney Damage

NCT02239016 | Completed

• 1 other identifier: 2009-0026
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of progression of microalbuminuria.

  Baseline through 36 months

Secondary Outcomes (1)

• Evaluation of novel urinary biomarkers.

  baseline, year 1, year 2 and year 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sickle cell clinics at various universities and hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (4)

Emory University (Children's Healthcare of Atlanta Pediatric Hospital)

Atlanta, Georgia, 30322, United States

Location

Univeristy of Louisville (Kosair Children's Hospital)

Louisville, Kentucky, 40202, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Akron Childen's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (2)

• 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.

  PMID: 21630304 RESULT

• Niss O, Lane A, Asnani MR, Yee ME, Raj A, Creary S, Fitzhugh C, Bodas P, Saraf SL, Sarnaik S, Devarajan P, Malik P. Progression of albuminuria in patients with sickle cell anemia: a multicenter, longitudinal study. Blood Adv. 2020 Apr 14;4(7):1501-1511. doi: 10.1182/bloodadvances.2019001378.

  PMID: 32289161 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, whole blood and serum

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Punam Malik, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: September 12, 2014
• Study Start: April 1, 2009
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

US (4)