Status:
RECRUITING
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Chronic Kidney Disease
Renal Anemia
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines...
Eligibility Criteria
Inclusion
- Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants).
- Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \< 60 mL/min per 1.73 m\^2.
- ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g/dL; ESA-naïve participants can have a Hb level ≤ 11 g/dL.
- Participant has a ferritin level \> 100 ng/mL or a transferrin saturation (TSAT) value \> 20%.
- Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit.
- Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:
- ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening.
- ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated with and discontinued an ESA ≥ 8 weeks prior to screening.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 4 weeks after final study intervention administration.
- Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose.
- Female participant must not donate ova starting at first administration of roxadustat and throughout the study period and for 4 weeks post-last roxadustat dose.
- Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 weeks post-last roxadustat dose.
- Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose.
- Male participants with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 4 weeks post-last roxadustat dose.
- Participant and/or participant's parent or legal guardian agrees for the participant not to participate in another interventional study while participating in the present study.
Exclusion
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has any medical condition, including active, systemic or clinically significant infection which may pose a safety risk to a participant in this study, which may confound the safety or activity assessment or may interfere with study participation making the participant unsuitable for study.
- Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any components of the formulation used.
- Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140/90 mm Hg \[whichever is lower\] for participants \< 13 years of age and ≥ 140/90 mm Hg for participants ≥ 13 years of age measured 3 times at the same visit) in the 2 weeks prior to screening.
- Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia, hemoglobin sickle cell disease, or hemoglobin sickle cell beta thalassemia).
- Participant has untreated hypothyroidism.
- Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg/mL intact PTH within 4 weeks of screening.
- Participant has a functioning kidney allograft.
- Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening.
- Participant has a known active malignancy or malignancy within 18 months before the screening visit. Radiation or chemotherapy must be completed at least 12 months before the screening visit.
- Participant has a scheduled living donor organ transplantation date within 12 weeks of screening. If participant becomes eligible for a kidney transplant during study conduct, the participant should be discontinued.
- Participant has a whole blood or packed red blood cells (pRBC) transfusion during the 8 weeks prior to screening.
- Participant has any current condition leading to active significant blood loss in the past 4 weeks.
- Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening.
- Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable hemoglobin (Hb), normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening.
- Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria.
- Participant had an episode of peritonitis within 30 days of screening.
- Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, immunoglobulin A (IgA) nephritis, rapidly progressive glomerulonephritis, membranoproliferative glomerulonephritis, antineutrophil cytoplasmic antibodies vasculitis) requiring pulse corticosteroid treatment or induction treatment with an immunosuppressive agent (i.e., cyclophosphamide, rituximab, or another monoclonal antibody) within 6 weeks of screening visit. Receipt of monoclonal antibody or biologic for maintenance treatment of underlying condition is acceptable.
- Participant has a known history of human immunodeficiency virus infection.
- Participant has rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or is allergic to peanut or soya.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05970172
Start Date
January 16 2024
End Date
October 30 2027
Last Update
December 17 2025
Active Locations (45)
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1
Site BE32002
Brussels, Belgium
2
Site BE32001
Edegem, Belgium
3
Site BE32004
Ghent, Belgium
4
Site BE32003
Leuven, Belgium