Study of Ravulizumab in Pediatric Participants with Primary IgAN

Study Identifier:
D928FC00002
ClinicalTrials.gov Identifier:
NCT07024563
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • IgAN
  • Chronic Kidney Disease
  • Immunoglobulin A Nephropathy
Study Drug
  • Drug: Ravulizumab
Date
Jun 2025 - Jul 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years
Requirements Information
Inclusion and Exclusion Criteria
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 RASI (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
Sex
Female & Male
Age
2 - 18 Years

Study Details

Medical Condition
  • IgAN
  • Chronic Kidney Disease
  • Immunoglobulin A Nephropathy
Study Drug
  • Drug: Ravulizumab
Date
Jun 2025 - Jul 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years years
Requirements Information
Inclusion and Exclusion Criteria
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 RASI (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

Protocol Summary

The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.

Trial Locations

Location
Status
Location
Research Site
Genova, Italy, 16147
Status
Recruiting
Location
Research Site
Roma, Italy, 00165
Status
Recruiting
Location
Research Site
Aurora, CO, United States, 80045
Status
Recruiting
Location
Research Site
Taipei, Unmapped, 10002
Status
Recruiting
Location
Research Site
Taoyuan, Unmapped, 333
Status
Recruiting
Location
Research Site
Torino, Italy, 10126
Status
Recruiting
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