Acute Kidney Injury in Patients With Sickle Cell Disease

• ClinicalTrials.gov Identifier: NCT03105271
• Recruitment Status: Completed
• First Posted: April 7, 2017
• Last Update Posted: February 7, 2022
• Sponsor: University of Alabama at Birmingham
• Collaborators: Pfizer; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: March 23, 2017
• First Posted Date: April 7, 2017
• Last Update Posted Date: February 7, 2022
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 13, 2017)

• 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
• 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.
• 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.

Original Primary Outcome Measures (submitted: April 3, 2017)

• 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
• 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, as determined by cystatin C, obtained during non-acute clinic visit both immediately prior to their AKI events and after AKI events.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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 *

• Baddam S, Aban I, Hilliard L, Howard T, Askenazi D, Lebensburger JD. Acute kidney injury during a pediatric sickle cell vaso-occlusive pain crisis. Pediatr Nephrol. 2017 Aug;32(8):1451-1456. doi: 10.1007/s00467-017-3623-6. Epub 2017 Feb 25.
• Lebensburger JD, Palabindela P, Howard TH, Feig DI, Aban I, Askenazi DJ. Prevalence of acute kidney injury during pediatric admissions for acute chest syndrome. Pediatr Nephrol. 2016 Aug;31(8):1363-8. doi: 10.1007/s00467-016-3370-0. Epub 2016 Mar 24.
• Oakley J, Zahr R, Aban I, Kulkarni V, Patel RP, Hurwitz J, Askenazi D, Hankins J, Lebensburger J. Acute Kidney Injury during Parvovirus B19-Induced Transient Aplastic Crisis in Sickle Cell Disease. Am J Hematol. 2018 May 14:10.1002/ajh.25140. doi: 10.1002/ajh.25140. Online ahead of print. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 31, 2022
• Actual Primary Completion Date: January 31, 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 information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

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

• Current Responsible Party: Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current

Collaborators

• Pfizer
• National Heart, Lung, and Blood Institute (NHLBI)

• Investigators: Not Provided
• PRS Account: University of Alabama at Birmingham
• Verification Date: February 2022