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Study identifier: NCT06047171 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Rescue of Nephrons With ALE.F02 (RENAL-F02)

Condition: Glomerulonephritis Rapidly Progressive  ·  Sponsor: Alentis Therapeutics AG

PhasePhase 2
Planned participants80
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV). AAV is a type of autoimmune disease where the body's own immune system attacks itself, and in the case of AAV the body attacks its own small blood vessels. There are many small blood vessels in the kidneys meaning the kidneys are commonly affected in AAV. The main questions it aims to answer are: * Is the new drug well tolerated and safe? * Can the new drug protect and preserve kidney functions when is added to standard therapy? Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has: * Group A: Standard treatment + ALE.F02 low dose infusions * Group B: Standard treatment + ALE.F02 high dose infusions * Group C: Standard treatment + ALE.F02 maximum dose infusions * Group D: Standard treatment + placebo infusions (inactive substance) The Treatment period will consist of 24 weeks beginning on Day 1, during which time participants will receive 13 infusions of the study medicine, along with standard therapy for kidney inflammation due to AAV. During the treatment period, participants will have the following assessments: * A brief physical examination focusing on their skin any pre-existing medical conditions that you have. * Collection of blood and urine samples for routine safety tests and to assess renal function. * C…

This description comes directly from the study's public registry record.

Talk to the study team

Mohamed Benabed  ·  +41 78 266 19 91  ·  mohamed.benabed@alentis.ch

Always discuss trial participation with your own doctor first.

Locations (51)

Vseobecna fakultni nemocnice v PrazePrague, CzechiaRecruiting
Institut klinicke a experimentalni medicinyPrague, CzechiaRecruiting
Aalborg University HospitalAalborg, DenmarkRecruiting
Aarhus University HospitalAarhus, DenmarkRecruiting
RigshospitaletCopenhagen, DenmarkRecruiting
Odense University HospitalOdense, DenmarkRecruiting
Centre Hospitalier Boulogne sur MerBoulogne-sur-Mer, Cedex, FranceRecruiting
CHU Bordeaux - Hopital PellegrinBordeaux, FranceRecruiting
CHRU de Brest - Hopital de la Cavale BlancheBrest, FranceRecruiting
CHU Grenoble-Alpes - Hopital MichallonLa Tronche, FranceRecruiting
CHU de Nantes - Hotel-DieuNantes, FranceRecruiting
CHU de NimesNîmes, FranceRecruiting

+ 39 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06047171