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New treatment option for Glomerulonephritis Rapidly Progressive
Official title Rescue of Nephrons With ALE.F02 (RENAL-F02)
ClinicalTrials.gov ID: NCT06047171
What this study is testing
What is ALE.F02?
ALE.F02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glomerulonephritis rapidly progressive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are male or female patients ≥18 years of age of any race or ethnicity with a score of \<7 on the Clinical Frailty Scale in the 3 months preceding the...
- Must be willing and able to comply with the study requirements and give informed consent for participation in the study;
- Must be willing to have a renal biopsy procedure performed no later than prior to study drug administration at the Week 6 Visit; alternatively, a...
- Have been newly diagnosed with RPGN within 45 days prior to the initiation of study drug treatment, as demonstrated by the following: - Evidence of...
- Are suspected of having RPGN attributed to AAV at Screening based on clinical laboratory diagnostic criteria, including a positive test for an ANCA...
You likely can't join if
- Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse);
- Have a positive serology test for anti-glomerular basement membrane antibodies;
- Have evidence of active or latent tuberculosis (TB) determined by a positive (not indeterminate) QuantiFERON®-TB Gold test (or equivalent). In...
- Have a chronic infection that could be exacerbated by RPGN or SOC therapy for RPGN;
- Have active hepatitis B, hepatitis C, or HIV infection;
- Have taken any prohibited medications.
See the full eligibility criteria
Who can join
- Are male or female patients ≥18 years of age of any race or ethnicity with a score of \<7 on the Clinical Frailty Scale in the 3 months preceding the onset of RPGN attributed to AAV; Note: The PI should assess the...
- Must be willing and able to comply with the study requirements and give informed consent for participation in the study;
- Must be willing to have a renal biopsy procedure performed no later than prior to study drug administration at the Week 6 Visit; alternatively, a historical biopsy performed up to 45 days prior to the initiation of...
- Have been newly diagnosed with RPGN within 45 days prior to the initiation of study drug treatment, as demonstrated by the following: - Evidence of loss of renal function with an eGFR of ≤50 mL/min/1.73 m2 and ≥10...
- Are suspected of having RPGN attributed to AAV at Screening based on clinical laboratory diagnostic criteria, including a positive test for an ANCA, ie, anti-myeloperoxidase (MPO) or anti-proteinase 3 (PR3);
- Have a body weight of ≤130 kg;
- Female patients must not be pregnant or lactating at Screening and 1 of the following conditions must apply: - Is a female of childbearing potential and agrees to use a highly effective method of birth control during...
- Female patients must agree not to donate ova for 6 months after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer;
- Male patients must agree to use contraception, in the form of either sexual abstinence or a condom, during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC...
- Male patients must agree to abstain from sperm donation during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of...
What rules you out
- Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse);
- Have a positive serology test for anti-glomerular basement membrane antibodies;
- Have evidence of active or latent tuberculosis (TB) determined by a positive (not indeterminate) QuantiFERON®-TB Gold test (or equivalent). In countries where QuantiFERON®-TB Gold test (or equivalent) is not available...
- Have a chronic infection that could be exacerbated by RPGN or SOC therapy for RPGN;
- Have active hepatitis B, hepatitis C, or HIV infection;
- Have taken any prohibited medications.
- Have received a course of SOC therapy which exceeds a high-dose prolonged regimen of treatment of ANCA RPGN, such as \>3000 mg of IV methylprednisolone-equipotent glucocorticoids, or \>1 mg/kg/day of oral...
- Have been treated or planned to be treated with avacopan;
- Have poor venous access;
- Have participated in an investigational drug or device study and received investigational therapy \<30 days or 5 half lives, whichever is the greater, prior to the first dose of study drug. For biological...
- Have a history of psoriasis, AD, excessively dry skin or recurrent conjunctivitis that has required treatment prescribed by a physician, scleroderma, vitiligo, or any other active autoimmune dermatological disorder...
- Have a diagnosis of systemic lupus erythematosus-AAV overlap syndrome;
- Have a diagnosis of eosinophilic granulomatosis with polyangiitis;
- Have evidence of uncontrolled respiratory, cardiac, hepatic, endocrine, central nervous system, or renal disease, unrelated to RPGN or AAV, that the PI believes cannot be readily brought under control, or any other...
- Have received a live vaccine within 30 days prior to Screening;
- Have received any vaccine within 7 days of the first dose of study drug other than against influenza or pneumococcal infection;
- Are employed by the PI or the study site, have direct involvement in the proposed study or other studies under the direction of that PI, or are a family member of the PI or study site personnel;
- Have not recovered from AEs and/or complications from major surgery prior to the first dose of study drug; Note: The PI should consult with the Medical Monitor and Sponsor to determine if ongoing, significant...
- Have active or known history of alcohol or substance abuse within 1 year prior to Day 1/Randomization or have a positive urine drug screen for drugs of abuse at Screening;
- Have been diagnosed within the preceding 5 years with a malignant neoplastic disease, other than locally invasive cutaneous squamous or basal cell carcinoma;
- Have alveolar haemorrhage with hypoxia defined by an oxygen saturation \<85% or that requires the use of invasive or noninvasive ventilatory support;
- Have undergone dialysis within 7 days prior to Screening;
- Have undergone therapeutic plasma exchange within 7 days prior to the first dose of study drug; or
- Have known hypersensitivity to the study drug or any of the excipients used in the formulation of the study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
- Boulogne-sur-Mer, Cedex, France
- Bordeaux, France
- Brest, France
- La Tronche, France
- Nantes, France
- Nîmes, France
- Paris, France
- Toulouse, France
- Valenciennes, France
- Berlin, Germany
- Cologne, Germany
- Dresden, Germany
- Essen, Germany
- Hanover, Germany
- Leipzig, Germany
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia; Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark; Boulogne-sur-Mer, Cedex, France and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.