A Phase II, multicenter, randomized, open label two arm study comparing the effect of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients * 16 years with chronic kidney disease due to sickle cell nephropathy

Phase 2

Completed

Conditions: sickle cell anemia
sickle cell disease
10018902

Registration Number: NL-OMON55208

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

1. Male and female patients * 16 years on the day that signed informed consent
is obtained
2. Confirmed diagnosis of SCD. Homozygous HbS and HbS*0-thal SCD genotypes are
eligible
3. 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)
4. ACR of * 100 to < 2000 mg/g (taken as an average of the three screening ACR
values to determine eligibility)
5. Receiving standard of care drug(s) for SCD and/or CKD.
6. Hb * 4.0 g/dL, ANC * 1.0 x 109/L, and platelet count * 75 x 109/L
7. ECOG performance status * 2.0

Exclusion Criteria

1. History of stem cell transplant
2. 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)
3. Blood pressure > 140/90 mmHg despite treatment
4.Patients undergoing renal replacement therapy (i.e. hemodialysis, peritoneal
dialysis, hemofiltration and kidney transplantation)
5. Participating in a chronic transfusion program
6. History of kidney transplant
7. Patients with hypoalbuminemia
8.Patient has received crizanlizumab and/or other selectin inhibitor or plans
to receive it during the duration of the study
9. History of or current diagnosis of ECG abnormalities indicating significant
risk of safety
10. Current drug or alcohol abuse:
11. Pregnant or nursing (lactating) women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with * 30% decrease in ACR at 12 months compared to<br /><br>baseline</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean change in ACR from baseline to 3, 6, 9, and 12 months of treatment<br /><br>Proportion of patients with * 30% decrease in ACR at 6 months compared to<br /><br>baseline<br /><br><br /><br>Proportion of patients with * 20% improvement of PCR at 12 months compared to<br /><br>baseline<br /><br>Proportion of patients with a stable (within ± 20% change) PCR at 12 months<br /><br>compared to baseline<br /><br><br /><br>Percentage change in eGFR from baseline to 3, 6, 9, and 12 months of treatment</p><br>