Status:

RECRUITING

The Predictive Capacity of Machine Learning Models for Progressive Kidney Disease in Individuals With Sickle Cell Anemia

Lead Sponsor:

University of Tennessee

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

University of Illinois at Chicago

Conditions:

Sickle Cell Disease

Kidney Diseases, Chronic

Eligibility:

All Genders

18-65 years

Brief Summary

This is a multicenter prospective, longitudinal cohort study which will evaluate the predictive capacity of machine learning (ML) models for progression of CKD in eligible patients for a minimum of 12...

Detailed Description

Sickle cell disease (SCD) is characterized by a vasculopathy affecting multiple end organs, with complications including ischemic stroke, pulmonary hypertension, and chronic kidney disease (CKD). Albu...

Eligibility Criteria

Inclusion

  • HbSS or HbSβ0 thalassemia, 18 - 65 years old;
  • non-crisis, "steady state" with no acute pain episodes requiring medical contact in preceding 4 weeks;
  • ability to understand the study requirements.

Exclusion

  • pregnant at enrollment;
  • poorly controlled hypertension;
  • long-standing diabetes with suspicion for diabetic nephropathy;
  • connective tissue disease such as systemic lupus erythematosus (SLE);
  • polycystic kidney disease or glomerular disease unrelated to SCD;
  • stem cell transplantation;
  • untreated human immunodeficiency virus (HIV), hepatitis B or C infection; h) history of cancer in last 5 years; i) End-stage renal disease (ESRD) on chronic dialysis; j) prior kidney transplantation.

Key Trial Info

Start Date :

July 5 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT05214105

Start Date

July 5 2022

End Date

January 31 2026

Last Update

December 14 2023

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

2

Wake Forest University

Winston-Salem, North Carolina, United States, 27109

3

The University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38104