Ravulizumab for children with IgA nephropathy or IgA vasculitis nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study gives intravenous ravulizumab to pediatric participants to characterize pharmacokinetics and pharmacodynamics and to monitor safety and signs of efficacy. Eligible children have biopsy‑proven primary IgA nephropathy or IgA vasculitis nephritis, proteinuria (UPCR ≥ 1.0 g/g), and estimated GFR ≥ 30 mL/min/1.73 m2 and must be on stable RAAS blockade. Dosing and follow‑up include repeated clinic visits and laboratory assessments over an extended period (protocol references include stability requirements through Week 34 and Week 106). Vaccination against meningococcus, Haemophilus influenzae type b, and Streptococcus pneumoniae is required prior to dosing and participants must be able to attend one of the participating study sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent.
* Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior 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 week during 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-1 agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 34.
* Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period

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 in proteinuria within the last 6 months.
* Uncontrolled diabetes mellitus with HbA1c \> 8.5%
* History of kidney transplant or planned kidney transplant during the Primary Evaluation Period.
* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant
* Splenectomy or functional asplenia
* Participants with nephrotic syndrome receiving albumin infusions or with acute kidney 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 study time frame.
* Congenital immunodeficiency
* Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment
* Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening

Where it's running

• Research Site
  Aurora, Colorado, United States Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Shanghai, China Recruiting
• Research Site
  Genova, Italy Recruiting
• Research Site
  Roma, Italy Recruiting
• Research Site
  Torino, Italy Recruiting

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of pediatric kidney diseases with Sparsentan

  This study is testing if a new oral medication called Sparsentan can help children aged 1 to 18 with certain kidney diseases feel better and improve their condition over two years.

  Recruiting at 38 sites Phase 2 Travere Therapeutics, Inc. · Los Angeles, California and 46 other locations · NCT05003986

• I-FABP as a Predictor of Gut Involvement in Pediatric IgA Vasculitis

  This study checks if a blood marker called I-FABP can flag gut involvement in kids with IgA vasculitis by testing blood at diagnosis and again in 2–4 weeks.

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• Safety and helpful dose test of STL303 in adults with IgA nephropathy

  A small, multi-center study will test different doses of STL303 or placebo to see if it helps adults with primary IgA nephropathy.

  Recruiting at 6 sites Phase 2 Sitala Bio LTD · Newcastle, New South Wales and 7 other locations · NCT07606352

• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

  This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.

  Recruiting at 8 sites Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07596784

• Ravulizumab in Chinese adults with NMOSD

  This study tests ravulizumab in Chinese adults with NMOSD who are AQP4 antibody positive to see if it helps reduce relapses and is safe.

  Recruiting Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07557420

• Atrasentan for pediatric primary IgA nephropathy

  This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.

  Recruiting at 19 sites Phase 3 Novartis · Neptune City, New Jersey and 22 other locations · NCT07498335

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.