Phase 2
Completed N=58
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Sickle Cell Disease (SCD)
Source: ClinicalTrials.gov NCT04053764 ↗
Enrolled (actual)
58
Serious AEs
7.0%
Results posted
Jun 2024
Primary outcomePrimary: Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months — 33.3; 21.4 Percentage of participants
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 kidney disease due to sickle cell nephropathy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months |
33.3; 21.4 | — |
| SECONDARY Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months |
597.0; 499.0; -56.9; 159.0; -98.5; -35.4 | — |
| SECONDARY Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months |
30.0; 35.7 | — |
| SECONDARY Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months |
33.3; 35.7; 16.7; 25.0 | — |
| SECONDARY Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) |
-2.5; -0.5; -2.7; -7.3; -0.2; -2.7 | — |
| SECONDARY Slope of Albumin to Creatinine Ratio (ACR) Decline |
1.70; 4.49 | — |
| SECONDARY Slope of Estimated Glomerular Filtration Rate (eGFR) Decline |
-0.1; -0.4 | — |
| SECONDARY Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months |
13.3; 32.1 | — |
| SECONDARY Shift Table for Chronic Kidney Disease (CKD) Progression |
3.3; 14.3; 8.6; 100.0; 75.0; 80.0 | — |
| SECONDARY Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab |
0; 3.4; 0; 89.7; 6.9 | — |
| SECONDARY Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations |
0.6; 1.1 | — |
| SECONDARY Mean Serum Concentration (Ctrough) of Crizanlizumab |
11.6; 12.1; 4.78; 5.67; 4.77; 5.54 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04053764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.