EUCTR2018-003608-38-GB
Active, not recruiting
Phase 1
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 (STEADFAST) - STEADFAST
ConditionsSickle Cell DiseaseSickle Cell NephropathyMedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.1Level: LLTClassification code 10002077Term: Anaemia sickle cellSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- ovartis Pharma AG
- Enrollment
- 170
- Status
- Active, not recruiting
- Last Updated
- 5 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 \= 130 (women), \= 45 to \= 140 (men)
- •o Patients with ACR of \= 100 to \< 2000 mg/g
- •o Receiving at least 1 standard of care drug(s) for SCD related CKD according to local guidelines. 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 7
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 160
Exclusion Criteria
- •o History of stem cell transplant \- Patients with evidence of AKI within 3 months of study entry
- •o Blood pressure \> 130/80 mmHg despite treatment
- •o Patients undergoing hemodialysis
- •o Body mass index of \= 35
- •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
- •Additional protocol\-defined exclusion criteria may apply
Outcomes
Primary Outcomes
Not specified
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