Crizanlizumab vs SOC in SCD patients with chronic kidney disease
Research type
Research Study
Full title
A Phase II, multicenter, randomized, open label two arm study comparing the effect of crizanilumab + standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy (STEADFAST)
IRAS ID
269933
Contact name
Rachel Kesse-adu
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-003608-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 26 days
Research summary
Sickle cell disease (SCD) is an inherited rare blood disorder affecting red blood cells. These cells become sickle-shaped and have difficulty passing through small blood vessels. In SCD, blood vessels are damaged and sticky due to the ongoing chronic inflammation. This may lead to blocked blood vessels (vaso-occulsion), causing acute episodes of pain and organ damage. When the blood vessels in a kidney become blocked, unblocked, and blocked again over time, this can contribute to chronic kidney disease.
There are no prospective data demonstrating a long-term benefit of any treatment for CKD due to SCN and no treatments are approved for this indication.
The purpose of this study is to explore the effect of new drug called crizanlizumab on renal function in SCD patients with CKD who are receiving standard of care treatment for SCD and/or CKD. Participants will be divided in two groups.
In Group 1 participants will receive 5mg/kg dose of crizanlizumab + standard of care treatment and in Group 2 participants will receive standard of care treatment alone.
We expect that about 10 participants in 3 different hospitals will be enrolled in this study in the UKREC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1532
Date of REC Opinion
4 Dec 2019
REC opinion
Further Information Favourable Opinion