EUCTR2018-003608-38-GR
Active, not recruiting
Phase 1
A Phase II, multicenter, randomized, open label two arm study evaluatingthe effect of crizanlizumab + standard of care and standard of care aloneon renal function in sickle cell disease patients = 16 years with chronickidney disease due to sickle cell nephropathy (STEADFAST) - STEADFAST
DrugsAdakveo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •o Confirmed diagnosis of SCD (HbSS and HbSß0\-thal SCD genotypes are eligible)
- •o 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\)
- •o Patients with ACR of \= 100 to \< 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
- •o Receiving at least 1 standard of care drug(s) for SCD related CKD according to local guidelines. 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 prior to study entry
- •o Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
- •Additional inclusion criteria as per full protocol may apply.
- •Additional inclusion criteria as per full protocol may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •o History of stem cell transplant
- •o 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)
- •o Blood pressure \> 140/90 mmHg despite treatment
- •o Body mass index of \= 35
- •o Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis,
- •hemofiltration and kidney transplantation)
- •o Received blood products within 30 days of Week 1 Day 1
- •o Participating in a chronic transfusion program
- •o History of kidney transplant
- •o Patients with hypoalbuminemia defined as \<25 g/L
Outcomes
Primary Outcomes
Not specified
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