About the VALOR-CKD Trial

The VALOR-CKD trial is a research study that is evaluating the efficacy and safety of the investigational drug veverimer (also known as TRC101) in delaying the progression of chronic kidney disease (CKD) in patients with metabolic acidosis and CKD.

This is an outcomes trial that is enrolling patients worldwide.  The primary endpoint of the study is progression of CKD, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in estimated glomerular filtration rate (eGFR), end-stage renal disease (ESRD), and renal death.

The VALOR-CKD trial is being conducted by Tricida, Inc.  It is also known as the TRCA-303 trial and can be found on ClinicalTrials.gov under the identifier number NCT03710291.

About Metabolic Acidosis

It is estimated that about 3 million patients with CKD have metabolic acidosis.  Metabolic acidosis is caused by the inability of the kidneys to excrete acid, and if left untreated, increases the risk of kidney failure and can lead to muscle protein catabolism, muscle loss, and bone demineralization.1, 2, 3   At this time, there are no FDA-approved treatments for chronic metabolic acidosis.

About Veverimer

Veverimer is an investigational, non-absorbed polymer drug that is designed to bind and remove acid from the gastrointestinal tract.4 Veverimer is being developed to slow CKD progression in patients with metabolic acidosis and CKD.

Criteria for Patient Referral

If your patient meets the following criteria, they may be eligible to participate in the trial:
  1. Has chronic kidney disease with recent estimated glomerular filtration rate (eGFR) between 18 and 43 mL/min/1.73m2.
  2. Has low serum bicarbonate or carbon dioxide (CO2 or CO2, total) on recent metabolic/chemistry panel (< 21 mmol/L).
  3. Is aged 18 to 85 years.
  4. Is not currently on dialysis or post-kidney transplant.

Find a VALOR-CKD Clinical Trial Site in the US

Refer a patient:

VALOR-CKD

Thank you for your interest in the VALOR-CKD trial.  If you would like to learn more, or if you have a patient that you would like to refer to the trial, please complete the form below and our clinical trial management team will contact you shortly.  

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The VALOR-CKD trial is sponsored by Tricida, Inc.Tricida

References

  1. Kraut JA, et al. Adv Chronic Kidney Dis. 2017;24(5):289-297.
  2. Welbourne T, et al. J Clin Invest. 1972;51(7):1852-1860.
  3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney inter., Suppl. 2013; 3: 1-150.
  4. Klaerner G, et al. “Mechanism of Action of Veverimer: A Novel, Orally Administered, Nonabsorbed, Counterion-Free, Hydrochloric Acid Binder under Development for the Treatment of Metabolic Acidosis in Chronic Kidney Disease.” Journal of Pharmacology and Experimental Therapeutics 375.3 (2020): 439-450.