Non-Dialysis Dependent Chronic Kidney Disease Patients With Anemia Study, To Compare Vadadustat Anemia Pill With Standard Of Care Injections
Posted Date: Jan 12, 2018
- Investigator: Shashi Kant
- Type of Study: Drug
The study drug (vadadustat, also called AKB-6548) is an investigational drug. It will be referred to as the “study drug” in this document, and any treatment in the study (including the study drug) may be referred to as “study medication”. This potential new drug is being tested to treat anemia (low red blood cell count) in patients with chronic (long-term) kidney disease. Anemia is a common health problem in people with chronic kidney disease. It can lead to feeling tired, shortness of breath, problems sleeping or thinking clearly, trouble fighting off infections, and long-term problems with organ health. Many medications have been developed to treat anemia. Some are given directly into the vein, some are injected under the skin, and others can be taken by mouth. Some treatments that are currently used to treat anemia may cause side effects in some patients. This study is being done to see if the investigational drug (vadadustat) is safe and effective in treating anemia and has fewer side effects than a currently used prescription medication (darbepoetin alfa).
Diagnosis Of Chronic Kidney Disease Egfr <=60, Screening Hgb <10 G/Dl, Adequate Iron Stores. Anemia Due To Causes Other Than Ckd Is Exclusion. No Hematologic Disorders, Iv Iron Within Last 4 Weeks, Current Injections For Anemia. No Uncontrolled Hypertension, Cancer, Current Active Heart Disease, Recent Dvt, Prior Organ Transplantation. Prior Experience With Hif-Phi Drug Or Sensitivity To Aranesp Is Exclusion. Both Men And Women Must Use Adequate Birth Control. Patients Able To Travel To Dci Mcmillan Research Offices. Study May Last For Four Years.
Anemia, Erythropoeisis Stimulating Agent, Chronic Kidney Disease, Null, Null
For More Information:
Karen Case, Ccrp