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New treatment option for Chronic Kidney Disease
Official title A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05970172
What this study is testing
What is Roxadustat?
Roxadustat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease.
Also referred to as ASP1517, FG-4592.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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...
- 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...
- 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) ≤...
You likely can't join if
- 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...
- Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any...
- Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140/90 mm Hg [whichever is lower] for participants \< 13...
- Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia...
- Participant has untreated hypothyroidism.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 treatment study while participating in the present study.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Sofia, Bulgaria
- Zagreb, Croatia
- Brno, Czechia
- Prague, Czechia
- Aarhus, Denmark
- Helsinki, Finland
- Tübingen, Germany
- Athens, Greece
- Thessaloniki, Greece
- Dublin, Ireland
- Milan, Italy
- Padova, Italy
- El Achrafiyé, Lebanon
- Vilnius, Lithuania
- Rotterdam, Netherlands
- Oslo, Norway
+ 22 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Edegem, Belgium; Ghent, Belgium; Leuven, Belgium; Sofia, Bulgaria; Zagreb, Croatia and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.