In a recent press release, biopharmaceutical company Akebia Therapeutics (“Akebia”) announced the publication of the Phase 3 INNO2VATE study design and methodology. The publication examines the INNO2VATE trial, which evaluated vadadustat for patients with anemia of chronic kidney disease (CKD). You can find the full details in Nephrology Dialysis Transplantation.
For 13 years, Akebia has been working to improve the lives of patients with kidney disease. Now, they have the potential to do so with vadadustat. This orally-administered hypoxia-inducible factor propel hydroxylase (HIF-PH) inhibitor was specifically developed to treat anemia of CKD. While it is not yet approved in the United States, it as approved for anemia of CKD in Japan. Vadadustat works by stabilizing HIF and mimicking the physiologic effect of altitude on oxygen availability. Basically, as HIF is stabilized, red blood cells are produced at a higher ratio, creating more tissue oxygenation. Since patients with anemia of CKD often struggle with red blood cell counts, vadadustat offers the ability to improve oxygenation.
In the newly published manuscript, Akebia details how the Phase 3 INNO2VATE trials were designed, as well as what methodology was being used. Additional information includes:
- Patient demographics
- Baseline patient characteristics
- Safety, efficacy, and tolerability of vadadustat in comparison to darbepoetin alfa
Ultimately, vadadustat was safe and well-tolerated. It reached both its primary and secondary safety and efficacy endpoints. As a result, it seems like a potentially promising treatment option for the future.
Chronic Kidney Disease (CKD)
Typically, chronic kidney disease (CKD), or chronic kidney failure, occurs following another disease or condition that inhibits kidney function. As a result, the kidneys become progressively more damaged. When kidney function worsens, your body is unable to filter out waste or excess fluid from the blood. As these wastes accumulate, it causes health complications. An estimated 26 million Americans have CKD. Risk factors and conditions include diabetes, high blood pressure, pyelonephritis, polycystic kidney disease, and glomerulonephritis, among others.
Symptoms of CKD include:
- Nausea and vomiting
- Appetite loss
- Liver and spleen enlargement
- Fatigue and general malaise
- Swelling of the lower extremities
- Jaundice (yellowing of the skin and eyes)
- Pruritus (persistent and intense itching)
- High blood pressure
- Shortness of breath / difficulty breathing
- Stunted growth
- Vitamin deficiencies
- Muscle aches
Anemia is another condition associated with CKD; in this case, it is called anemia of CKD. Because patients with CKD do not produce enough of the hormone erythropoietin, which normally helps regulate red blood cell production, they develop anemia (low red blood cell count). This can cause additional health issues and greatly reduce quality of life (QOL).