Status:
COMPLETED
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sickle Cell Disease (SCD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic ...
Detailed Description
Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic k...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
- Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients \< 18)
- Patients with ACR of ≥ 100 to \< 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
- Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
- Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, and platelet count ≥ 75 x 10\^9/L
- Adequate hepatic function as defined by:
- Alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN)
- Direct (conjugated) bilirubin ≤ 3.0 x ULN
- Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Exclusion
- History of stem cell transplant
- Patients with evidence of AKI within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
- Blood pressure \> 140/90 mmHg despite treatment
- Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
- Received blood products within 30 days of Week 1 Day 1
- Participating in a chronic transfusion program
- History of kidney transplant
- Patients with hypoalbuminemia
- Body mass index of ≥ 35
- Currently receiving or received voxelotor within 6 months of screening
- Patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study.
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04053764
Start Date
December 10 2019
End Date
March 20 2023
Last Update
October 9 2024
Active Locations (24)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
University of Illinois Hospital and Health Sciences System .
Chicago, Illinois, United States, 60612
3
Our Lady of the Lake Regional Medic .
Baton Rouge, Louisiana, United States, 70809
4
East Carolina University BrodySchool of Med 3
Greenville, North Carolina, United States, 27858