Recruiting NCT07024563

Study of Ravulizumab in Pediatric Participants With Primary IgAN

Phase III Interventional IgAN IgAVN Immunoglobulin A Nephropathy Immunoglobulin A Vasculitis Associated Nephritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ravulizumab.
Who it may be relevant to: Registry conditions: IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis. Basic parameters: 2 years — 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, China, Italy, Japan, South Korea +2
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to < 18 Years of Age) With Primary Immunoglobulin A Nephropathy (IgAN)

Overview

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.

Interventions

Drug Ravulizumab
Participants will receive Ravulizumab via intravenous (IV) infusion.

Primary outcome measures

Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34 [Time frame: Baseline, Week 34]

Secondary outcome measures (11)

Maximum Observed Plasma Concentration (Cmax) of Ravulizumab [Time frame: Baseline up to Week 34]
Trough Serum Concentration (Ctrough) of Ravulizumab [Time frame: Baseline up to Week 34]
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration [Time frame: Baseline up to Week 34]
Change from Baseline in proteinuria based on Urine Protein to Creatinine Ratio (UPCR) at Week 10 [Time frame: Baseline, Week 10]
Change from Baseline in Albuminuria based on Urine Albumin to Creatinine Ratio (UACR) at Week 34 [Time frame: Baseline, Week 34]
Number of Participants with Partial Remission [Time frame: Week 34]
Annualized Total Estimated Glomerular Filtraion Rate (eGFR) over 106 weeks [Time frame: Baseline up to Week 106]
Change from Baseline in eGFR [Time frame: Baseline, Weeks 50 and 106]
Number of Participants with UPCR <0.5 gram of protein per gram of creatinine [Time frame: Week 34]
Number of Participants With Treatment Emergent Adverse Events, Treatment Emergent Serious Adverse Events and Adverse Events of Special Interest [Time frame: Baseline up to Week 106]
Number of Participants with Antidrug Antibodies to Ravulizumab and Neutralizing Antibodies [Time frame: Baseline up to Week 106]

Eligibility 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Spain · 4 centers

Research Site — Almería
Research Site — Barcelona
Research Site — Barcelona
Research Site — Seville

Italy · 3 centers

Research Site — Genova
Research Site — Roma
Research Site — Torino

United States · 2 centers

Research Site — Palo Alto
Research Site — Aurora

China · 2 centers

Research Site — Beijing
Research Site — Shanghai

Taiwan · 2 centers

Research Site — Taipei
Research Site — Taoyuan

Japan · 1 center

Research Site — Wakayama

South Korea · 1 center

Research Site — Seoul

Identifiers

NCT: NCT07024563 · D928FC00002 · 2024-520167-13-00 · ALXN1210-IgAN-325

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗