Study of Ravulizumab in Pediatric Participants With Primary IgAN

Study Purpose

The primary objective of this study is to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 18 Years
Gender	All

More Inclusion & 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 ≥ 0.5 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.

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.

- 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 ≤ 6 months prior to Screening

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07024563
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alexion Pharmaceuticals, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	China, Italy, Korea, Republic of, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis, Henoch-schonlein Purpura Nephritis, IgA Vasculitis

Arms & Interventions

Arms

Experimental: Ravulizumab

All participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and either once every 8 weeks (q8w) thereafter or once every 4 weeks (q4w) depending on weight.

Interventions

Drug: - Ravulizumab

Participants will receive Ravulizumab via intravenous (IV) infusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Aurora, Colorado

Status

Address

Research Site

Aurora, Colorado, 80045

Site Contact

[email protected]

1-855-752-2356