Acute Kidney Injury in Patients With Sickle Cell Disease

NCT03105271

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35223, United States
Contact
205 638-9285

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Disease, Kidney Injury, Kidney Diseases, Chronic Kidney Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-25 year
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome

- Able to sign informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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Sickle Cell Disease, Kidney Injury, Kidney Diseases, Chronic Kidney DiseaseAcute Kidney Injury in Patients With Sickle Cell Disease
NCT03105271
  1. Birmingham, Alabama
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Acute Kidney Injury in Patients With Sickle Cell Disease
Official Title Acute Kidney Injury in Patients With Sickle Cell Disease
Brief Summary Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up.
Detailed Description

Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may consent to participate in this study. Patients will consent to daily blood and urine collection during their hospitalization and during well clinic visits.

Each AM, participants will have blood and urine collected, processed, and strored for future analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO definition based on either a rise in serum creatinine or decline in urine output. Patient medical course will be reviewed to determine interventions and outcomes of their admission based on the development of AKI.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine and blood will be stored in biorepository.
Sampling Method Non-Probability Sample
Study Population Patients with HbSS or SB0 thalassemia admitted to Children's of Alabama for a vaso-occlusive pain crisis or acute chest syndrome.
Condition
  • Sickle Cell Disease
  • Kidney Injury
  • Kidney Diseases
  • Kidney Disease, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2017)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome
  • Able to sign informed consent

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study:All
Ages 1 Year to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jeffrey D Lebensburger, DO MSPH205 638-9285[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03105271
Other Study ID Numbers AKISCD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators
  • Pfizer
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators Not Provided
PRS Account University of Alabama at Birmingham
Verification Date March 2020