Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Di… (NCT04053764) | Clinical Trial Compass
CompletedPhase 2
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
United States58 participantsStarted 2019-12-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 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 Criteria:
* 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 …
What they're measuring
1
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months