Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants Wit⦠(NCT05745883) | Clinical Trial Compass
CompletedPhase 1
Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia
United States55 participantsStarted 2023-04-04
Plain-language summary
This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Aged β₯18 years of age at the time of signing informed consent.
β. Non-dialysis-dependent chronic kidney disease, Stages 2-5, defined as eGFR \<90 mL/min/1.73 m2 using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
β. Hgb \<11.0 g/dL
β. Serum ferritin β₯50 ΞΌg/L at screening
β. Transferrin saturation β€35%
β. AST and ALT \<2Γ upper limit of normal (ULN) at screening
β. Total and direct bilirubin \<ULN at screening
β. If female, then EITHER postmenopausal, defined as at least 12 months of natural, spontaneous amenorrhea and serum follicle-stimulating hormone \>40 mIU/mL at screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy or hysterectomy); OR agreeable to use of highly effective contraception (listed below) on Day 1 (or earlier) for at least 8 weeks after the last dose of study drug:
Exclusion criteria
β. Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to signing the informed consent form (ICF) and screening for oral iron or iron-containing supplements. Between screening and 2 days prior to baseline visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron
β
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: up to 145 days
2
Incidence of clinically abnormal vital signs
Timeframe: up to 145 days
3
Incidence of abnormal laboratory test results
Timeframe: up to 145 days
4
Incidence of clinically abnormal physical exam
Timeframe: up to 145 days
5
Incidence of clinically abnormal electrocardiograms
. Treatment within 30 days prior to screening with one of the following anemia treatments: blood transfusion, ESAs, or IV iron. Participants may be considered for the study if they undergo a 30-day washout period prior to signing the ICF and screening for erythropoietin-stimulating agents or IV iron
β. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 24 weeks of screening
β. Hospitalization for a CV, renal, or cardiorenal condition within 30 days prior to screening
β. Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia. This test can be performed prior to other screening procedures after the participant is consented for the prescreening testing
β. History of hereditary hemochromatosis
β. History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia