REscue of Nephrons with ALe.F02 (RENAL F02)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody Associated Vasculitis with Rapidly Progressive Glomerulonephritis
IRAS ID
1007507
Contact name
Kelvin Ho
Contact email
Sponsor organisation
Alentis Therapeutics AG
Eudract number
2022-502184-38
Research summary
Rapidly progressive glomerulonephritis (RPGN) is a disorder that causes rapid deterioration of kidney function. ALE.F02 is an investigational (not approved) drug for the treatment of RPGN associated with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a disease in which the patient’s immune system attacks their own blood vessels. AAV frequently affect kidneys causing RPGN.
RPGN is a rare syndrome but has a high rate of kidney failure associated with it. Patients are also typically older adults (>50 years of age) and are thus more likely to be suffering from other conditions affecting their overall health. The current standard of care medication for this condition has suboptimal effectiveness with incomplete remissions (disappearance of disease symptoms), relapses, and loss of kidney function complicating the course of the disease. Hence, there is an unmet medical need to improve outcomes in RPGN, in particular the protection and preservation of kidney function.The purpose of this study is to learn about the safety, tolerability and effectiveness of ALE.F02 when added to the standard of care in patients with RPGN caused by AAV.
This study will assess how safe ALE.F02 is when compared to a placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and various other examinations will be used to look at the safety of ALE.F02.
This trial will be conducted at multiple research sites in Europe and the UK. Eligible participants will be randomly assigned to 1 of the 3 study treatment arms. Participants will have a 1 in 3 chance of receiving ALE.F02 low dose, ALE.F02 high dose or a placebo. All subjects will receive the standard of care in addition to ALE.F02 or placebo. The study consists of a Screening period of up to 2 weeks, a 24-week Treatment period and a 28-week Observation period.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0124
Date of REC Opinion
5 Oct 2023
REC opinion
Further Information Favourable Opinion