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Clinical Trials/LBCTR2024015495
LBCTR2024015495Not yet recruitingPhase 3

A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants with Chronic Kidney Disease -

Astellas0 sites100 target enrollmentStarted: March 7, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Astellas
Enrollment
100
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
2 to 18 (—)
Sex
All

Inclusion Criteria

  • •1. IRB/IEC approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for US study sites) must be obtained from the participant or participant’s parent or legal guardian, and if required, child assent, prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
  • •2. Participant is aged 2 to < 18 years old at the screening/first study visit.
  • •3. 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 DD participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants).
  • •4. Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of < 60 mL/min per 1.73 m2.
  • •5. 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.
  • •6. Participant has a ferritin level > 100 ng/mL or a TSAT value > 20%.
  • •7. Participant has an ALT and AST = 2 x ULN and TBL = 1.5 x ULN at enrollment visit.
  • •8. Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:
  • •a. ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening.
  • •b. 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.
  • •9. Female participant is not pregnant (see [Appendix 2]) and at least 1 of the following conditions apply:
  • •c. Not a WOCBP (see [Appendix 2])
  • •d. WOCBP who agrees to follow the contraceptive guidance (see [Appendix 2]) from the time of informed consent through at least 4 weeks after final study intervention administration.
  • •10. Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose.
  • •11. 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.
  • •12. Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception (see [Appendix 2]) throughout the treatment period and for 4 weeks post-last roxadustat dose.
  • •13. Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose.
  • •14. 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.
  • •15. 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 Criteria

  • •1. Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • •2. Participant has any medical condition, including active, systemic or clinically significant infection, which in the opinion of the investigator or medical monitor, 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.
  • •3. Participant has a known or suspected hypersensitivity to roxadustat, related HIF-PHI, or any components of the formulation used.
  • •4. Participant has uncontrolled hypertension as judged by the principal investigator in the 2 weeks prior to screening.
  • •5. 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).
  • •6. Participant has untreated hypothyroidism.
  • •7. Participant has severe hyperparathyroidism defined as serum PTH levels above 1000 pg/mL intact PTH within 4 weeks of screening.
  • •8. Participant has a functioning kidney allograft.
  • •9. Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening.
  • •10. 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.
  • •11. Participant has a scheduled living donor organ transplantation date within 12 weeks of screening.
  • •12. Participant has a whole blood or packed RBC transfusion during the 8 weeks prior to screening.
  • •13. Participant has any current condition leading to active significant blood loss in the past 4 weeks.
  • •14. Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening.
  • •a. Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable Hb, normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening.
  • •15. Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria.
  • •16. Participant had an episode of peritonitis within 30 days of screening.
  • •17. Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, 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.
  • •18. Participant has a known history of human immunodeficiency virus infection.

Investigators

Sponsor
Astellas

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