CTX001 for Anemia in Adults With Chronic Kidney Disease Not on Dialysis
Tests CTX001 in adults with anemia from chronic kidney disease, not on dialysis.
Plain-language title generated from the registry record
Registry title: Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Key facts
- Where
- Gosford, Perth, Southport, and St Leonards, AustraliaSee the 4 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07901933, who can take part
Where in Australia
- Renal Research GosfordGosford, AustraliaNo longer taking part
- Royal Perth HospitalPerth, AustraliaNo longer taking part
- AOVO Clinical TrialsSouthport, AustraliaNo longer taking part
- Royal North Shore HospitalSt Leonards, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cajal Therapeutics Inc.
- Trial code
- NCT07901933
- Record updated
- 28 October 2026
- Original description
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis.Read full original descriptionShow less
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis.
Inclusion: Between 18 and 75 years of age; Body mass index (BMI) between 18 and 35 kg/m2; Estimated GFR ≥15 and <60 mL/min/1.73 m2; CKD for at least 3 months; Not currently receiving dialysis and not expected to start dialysis within 3 months of screening; Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL; Transferrin saturation (TSAT) ≤20%; Not folate or vitamin B12 deficient; ALT and AST ≤1.5 x ULN and TBL ≤1.5 x ULN.
Exclusion: RBC transfusion, intravenous iron, or ESA use within 12 weeks prior to screening; Receiving an SGLT2 inhibitor on a dose that has not been stable for at least 12 weeks prior to screening; Has a concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study; Anemia due to a cause other than CKD, presence of active bleeding, or recent significant blood loss; Any hemoglobinopathy, bone marrow pathology or hematological malignancy, including, but not limited to sickle cell disease, thalassemia, myelodysplastic syndrome, bone marrow fibrosis, red cell aplasia; Known history of hemochromatosis or other iron-overload disorder, or ferritin >700 ng/mL; Has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs; Pregnant or breastfeeding; Is unable or unwilling to comply with protocol-specified sun protection and contraception requirements.