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New treatment option for aHUS
Official title Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
ClinicalTrials.gov ID: NCT07308574
What this study is testing
What is Ravulizumab?
Ravulizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ahus.
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 primary objective of this study is to assess the platelet count response to ravulizumab in participants clinically diagnosed as atypical hemolytic uremic syndrome (aHUS).
- Phase 4: studies an already-approved treatment
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
- Body weight ≥20 kilograms (kg)
- Participants clinically diagnosed as aHUS who have any of diseases/conditions listed below (including participants in whom Thrombotic microangiopathy...
- Infection (except for pneumococcal infection and Siga toxin-producing Escherichia coli infection)
- During pregnancy or postpartum
- Post-renal transplantation
You likely can't join if
- Participants with TTP, STEC-HUS, secondary TMA that is obviously unrelated to complement abnormality.
- Participants with TMA caused by malignant tumors, abnormal Cobalamin C metabolism, Streptococcus pneumoniae, drugs, autoimmune diseases other than...
- Participants with pathological complement gene variants (CFH, CFI , CD46 (MCP), C3, CFB, THBD, DGKE) associated with the development of aHUS at...
- Participants with positive anti-factor H antibodies
- More than 14 day from onset of TMA to the planned start of ravulizumab treatment
- Chronic kidney disease or irreversible renal impairment that requires chronic dialysis
See the full eligibility criteria
- Body weight ≥20 kilograms (kg)
- Participants clinically diagnosed as aHUS who have any of diseases/conditions listed below (including participants in whom Thrombotic microangiopathy (TMA) has not been improved even after treatment for the pathogenesis...
- Infection (except for pneumococcal infection and Siga toxin-producing Escherichia coli infection)
- During pregnancy or postpartum
- Post-renal transplantation
- Hypertensive crisis/malignant hypertension
- Systemic lupus erythematosus and related diseases (e.g. dermatomyositis, mixed connective tissue disease, etc.)
- Participants with the following three signs:
- Thrombocytopenia: Platelet count \<150,000/microliter (μL)
- Microangiopathic haemolytic anaemia: Hb \< 10 grams per deciliter (g/dL) (\ )
- Acute kidney injury: one of the following is fulfilled; 1. ΔsCr ≥ 0.3 milligrams per deciliter (mg/dL) (within 48 hours), 2. 1.5-fold increase from baseline sCr (within 7 days), 3. urinary output ≤ 0.5 mL/kg/hour for ≥...
- No prior treatment with complement inhibitors.
- The investigator plans to provide the participant with 26-week treatment with ravulizumab in accordance with the treatment policy in clinical practice.
- Ravulizumab treatment is planned to be initiated within 14 days after onset of the latest TMA episode.
- Participants consenting to meningococcal vaccine administration and appropriate antibiotic prophylaxis (if required).
- Participants with TTP, STEC-HUS, secondary TMA that is obviously unrelated to complement abnormality.
- Participants with TMA caused by malignant tumors, abnormal Cobalamin C metabolism, Streptococcus pneumoniae, drugs, autoimmune diseases other than systemic lupus erythematosus and related diseases (e.g. scleroderma...
- Participants with pathological complement gene variants (CFH, CFI , CD46 (MCP), C3, CFB, THBD, DGKE) associated with the development of aHUS at enrolment
- Participants with positive anti-factor H antibodies
- More than 14 day from onset of TMA to the planned start of ravulizumab treatment
- Chronic kidney disease or irreversible renal impairment that requires chronic dialysis
- Presence of unresolved meningococcal disease
- Judgement by the investigator that the participant is not eligible for the study
The study team makes the final eligibility decision.
Where it's taking place
- Bunkyō City, Japan
- Hirakata-shi, Japan
- Iruma-Gun, Japan
- Kyoto, Japan
- Matsumoto-shi, Japan
- Miyazaki, Japan
- Nagoya, Japan
- Nara, Japan
- Nerima-ku, Japan
- Sapporo, Japan
- Shinjuku-ku, Japan
- Tsu, Japan
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 Bunkyō City, Japan; Hirakata-shi, Japan; Iruma-Gun, Japan; Kyoto, Japan; Matsumoto-shi, Japan; Miyazaki, Japan and 6 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.