Phase
Condition
Circulation Disorders
Dermatomyositis (Connective Tissue Disease)
Collagen Vascular Diseases
Treatment
Ravulizumab
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 2 to < 18 years of age at the time of signing the informedconsent or assent.
Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 monthsprior to Screening with no planned change during Screening through Week 106.
UPCR ≥ 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 weekduring the Screening Period
Estimated GFR ≥ 30 mL/min/1.73 m2 during Screening
Meningococcal infection vaccine
Haemophilus influenzae type b and Streptococcus pneumoniae vaccine
Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 monthsprior to Screening with no planned change in dose through Week 34.
Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3years prior to Screening or during the Screening Period
Exclusion
Exclusion Criteria:
Diagnosis of rapidly progressive glomerulonephritis
Secondary forms of IgAN not in the context of primary IgAN or IgAV
Concomitant clinically significant renal disease other than IgAN or IgAVN
Clinical remission of IgAN/IgAVN or clinically significant improvement inproteinuria within the last 6 months.
Uncontrolled diabetes mellitus with HbA1c > 8.5%
History of kidney transplant or planned kidney transplant during the PrimaryEvaluation Period.
History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bonemarrow transplant
Splenectomy or functional asplenia
Participants with nephrotic syndrome receiving albumin infusions or with acutekidney injury requiring dialysis within the last 6 months prior to Screening.
Hemolytic uremic syndrome diagnosed any time prior to Screening.
Planned urological surgery expected to influence kidney function within the studytime frame.
Congenital immunodeficiency
Active systemic bacterial, viral, or fungal infection within 14 days prior toenrollment
Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior toScreening
Study Design
Connect with a study center
Research Site
Beijing, 100045
ChinaActive - Recruiting
Research Site
Beijing 1816670, 100045
ChinaSite Not Available
Research Site
Shanghai, 201102
ChinaActive - Recruiting
Research Site
Shanghai 1796236, 201102
ChinaSite Not Available
Research Site
Genova, 16147
ItalyActive - Recruiting
Research Site
Genova 8969657, 16147
ItalySite Not Available
Research Site
Roma, 00165
ItalyActive - Recruiting
Research Site
Roma 8957247, 00165
ItalySite Not Available
Research Site
Torino, 10126
ItalyActive - Recruiting
Research Site
Torino 8980539, 10126
ItalySite Not Available
Research Site
Wakayama, 641-8510
JapanActive - Recruiting
Research Site
Wakayama 1926004, 641-8510
JapanSite Not Available
Research Site
Seoul, 03080
Korea, Republic ofSite Not Available
Research Site
Seoul, 03080
South KoreaActive - Recruiting
Research Site
Seoul 1835848, 03080
South KoreaSite Not Available
Research Site
Barcelona, 8950
SpainActive - Recruiting
Research Site
Barcelona 3128760, 8950
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Seville, 41013
SpainActive - Recruiting
Research Site
Seville 2510911, 41013
SpainSite Not Available
Research Site
Taipei, 10002
TaiwanActive - Recruiting
Research Site
Taipei 1668341, 10002
TaiwanSite Not Available
Research Site
Taoyuan City, 333
TaiwanSite Not Available
Research Site
Taoyuan District, 333
TaiwanActive - Recruiting
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Palo Alto, California 94304
United StatesSite Not Available
Research Site
Aurora, Colorado 80045
United StatesActive - Recruiting
Research Site
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available

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