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Compares treatment options for Atypical Hemolytic Uremic Syndrome
Official title Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
ClinicalTrials.gov ID: NCT05935215
What this study is testing
What is Iptacopan?
Iptacopan is an investigational medicine, being studied as a potential treatment for atypical hemolytic uremic syndrome.
Also referred to as LNP023.
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 purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Male and female adult participants ≥ 18 years of age with diagnosis of aHUS for whom etiologies of other types of TMA and non-aHUS kidney disease...
- In the opinion of the investigator the participant has responded to anti-C5 antibodytreatment prior to screening and has clinical evidence of...
- Hematological normalization in platelet count ≥150 x 10\^9/L and LDH below upper limit of normal [ULN], and
- Stable kidney function as defined by serum creatinine values within ±15% during the Screening period
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required prior to the start of treatment with iptacopan.
You likely can't join if
- History of aHUS disease relapse while on anti-C5 antibody treatment.
- eGFR \< 30 ml/min/1.73m\^2
- Active infection or history of recurrent invasive infections caused by encapsulated bacteria, i.e., meningococcus, pneumococcus (eg., N...
- Participants with sepsis or active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment...
- Kidney, bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT), heart, lung, small bowel, pancreas, liver transplantation or any...
- Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
See the full eligibility criteria
- Male and female adult participants ≥ 18 years of age with diagnosis of aHUS for whom etiologies of other types of TMA and non-aHUS kidney disease have been excluded. . Currently on the recommended (as per label) dosage...
- In the opinion of the investigator the participant has responded to anti-C5 antibodytreatment prior to screening and has clinical evidence of response (in absence of PE/PI) during the Screening period. Clinical evidence...
- Hematological normalization in platelet count ≥150 x 10\^9/L and LDH below upper limit of normal [ULN], and
- Stable kidney function as defined by serum creatinine values within ±15% during the Screening period
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required prior to the start of treatment with iptacopan.
- If not received previously or if a booster is required, vaccination against Haemophilus influenzae infection, should be given, if available and according to local regulations.
- History of aHUS disease relapse while on anti-C5 antibody treatment.
- eGFR \< 30 ml/min/1.73m\^2
- Active infection or history of recurrent invasive infections caused by encapsulated bacteria, i.e., meningococcus, pneumococcus (eg., N. meningitidis, S. pneumoniae) or H. influenzae.
- Participants with sepsis or active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.
- Kidney, bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT), heart, lung, small bowel, pancreas, liver transplantation or any other cell or solid organ transplantation
- Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
- Any medical condition deemed likely to interfere with the patient's participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Beijing, China
- Shanghai, China
- Bordeaux, France
- Paris, France
- Rouen, France
- Toulouse, France
- Tours, France
- Essen, Germany
- Kiel, Germany
- Ranica, BG, Italy
- Milan, MI, Italy
- Roma, RM, Italy
- Matsumoto-shi, Nagano, Japan
- Iruma-gun, Saitama, Japan
- Bunkyo Ku, Tokyo, Japan
- Santiago Compostela, A Coruna, Spain
- Barcelona, Spain
- Córdoba, Spain
- Málaga, Spain
+ 9 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Beijing, China; Shanghai, China; Bordeaux, France; Paris, France; Rouen, France and 23 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.