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NOT YET RECRUITING
NCT07901933
PHASE1

Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease

Sponsor: Cajal Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-11

Completion Date

2027-11

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

Placebo

Matching placebo administered orally once daily for 29 days.

DRUG

CTX001

CTX001 administered orally at the assigned cohort dose once daily for 29 days.

DRUG

Ferrous Sulfate

Ferrous sulfate administered orally once daily for 29 days in both treatment arms.

Locations (4)

Renal Research Gosford

Gosford, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

AOVO Clinical Trials

Southport, Queensland, Australia

Royal Perth Hospital

Perth, Western Australia, Australia