Study exploring the effect of crizanlizumab on kidney function in patients withchronic kidney disease caused by sickle cell disease

Phase 1

• Conditions: Sickle Cell Disease; Sickle Cell Nephropathy; MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: LLTClassification code 10002077Term: Anaemia sickle cellSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003608-38-GR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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
F.1.2.1 Number of subjects for this age range 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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

Additional protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified