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Acute Kidney Injury in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT03105271
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Pfizer
National Insitutes of Health, NHLBI
Information provided by (Responsible Party):
Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham

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.

Condition or disease
Sickle Cell Disease Kidney Injury Kidney Diseases Kidney Disease, Chronic

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Patients With Sickle Cell Disease
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of Acute Kidney Injury [ Time Frame: Hospitalizations through study completion, an average of one year ]
    Evaluate the incidence of KDIGO defined AKI among patients admitted for pain or acute chest syndrome. AKI is defined by KDIGO as an increase in SCr by 50% or ≥0.3mg/dL from baseline, or UOP <0.5mL/kg/hr for 12 hrs

  2. Impact of Acute Kidney Injury during Pain or Acute Chest Syndrome Hospitalizations on the Development of Chronic Kidney Disease as defined by KDIGO. [ Time Frame: One year ]
    We will evaluate the impact of AKI on eGFR. To evaluate this impact, we will compare the change in eGFR, as measured by cystatin C, obtained from each patient during their non-acute clinic visit both immediately prior to their AKI events and after AKI events.

  3. Impact of free heme and endothelin on development of AKI [ Time Frame: two years ]
    We will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI.


Biospecimen Retention:   Samples Without DNA
Urine and blood will be stored in biorepository.


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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:

-


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): NCT03105271


Contacts
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Contact: Jeffrey D Lebensburger, DO MSPH 205 638-9285 jlebensburger@peds.uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35223
Contact: Jeffrey D Lebensburger, DO       jlebensburger@peds.uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
National Insitutes of Health, NHLBI

Publications:
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Responsible Party: Jeffrey D. Lebensburger, DO, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03105271     History of Changes
Other Study ID Numbers: AKISCD
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency, Chronic
Anemia, Sickle Cell
Wounds and Injuries
Urologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Renal Insufficiency