Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Completed · Phase 2
Conditions studied: Sickle Cell Disease (SCD)
In brief
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.
Key facts
- Study ID
- NCT04053764
- Run by
- Novartis Pharmaceuticals
- People needed
- 58
- Starts
- 2019-12-10
- Expected to finish
- 2023-03-20
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- University of Illinois Hospital and Health Sciences System . — Chicago, Illinois, United States
- Our Lady of the Lake Regional Medic . — Baton Rouge, Louisiana, United States
- East Carolina University BrodySchool of Med 3 — Greenville, North Carolina, United States
- Univ of Tenn Health Sciences Ctr — Memphis, Tennessee, United States
- University of Texas Health Science Center at Houston — Houston, Texas, United States
- Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Porto Alegre, Brazil
- Novartis Investigative Site — Créteil, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Athens, Greece
- Novartis Investigative Site — Larissa, Greece
- Novartis Investigative Site — Dublin, Ireland
- Novartis Investigative Site — Tripoli, Lebanon
- Novartis Investigative Site — Amsterdam, Netherlands
- Novartis Investigative Site — Panama City, Panama
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Adana, Turkey (Türkiye)
- Novartis Investigative Site — Adana, Turkey (Türkiye)
- Novartis Investigative Site — Antakya / Hatay, Turkey (Türkiye)
- Novartis Investigative Site — London, United Kingdom
- Novartis Investigative Site — London, United Kingdom
- Novartis Investigative Site — London, United Kingdom
Full record on ClinicalTrials.gov
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