Trial DesignsCardiovascular safety and efficacy of vadadustat for the treatment of anemia in non-dialysis-dependent CKD: Design and baseline characteristics
Section snippets
METHODS
The PRO2TECT trials are two ongoing randomized, Phase 3, open-label, active-controlled clinical trials evaluating the safety and efficacy of oral vadadustat vs injectable darbepoetin alfa: PRO2TECT-Correction (previously ESA untreated; NCT02648347) and PRO2TECT-Conversion (previously ESA treated; NCT02680574). Target enrollment for each was approximately 1,850 patients recruited at approximately 390 and 480 sites in North America, Latin America, Europe, and the Asia Pacific for the
RESULTS
In total, 4,708 patients were screened for the ESA-untreated NDD-CKD trial, and 1,751 were randomized. Most (n = 1,061, 60.6%) were from the United States; the remainder were from Europe or non-US/non-Europe. A total of 2,961 patients were screened for the ESA-treated NDD-CKD trial, 1,725 of whom were randomized. Most (n = 1,060, 61.5%) were from Europe or non-US/non-Europe countries, and the remainder were from the United States. The most common reason for screen failure in both trials was an
DISCUSSION
The PRO2TECT program is designed to compare the safety and efficacy of oral vadadustat to injectable darbepoetin alfa in patients with anemia of NDD-CKD.
Although ESAs have helped to correct anemia and typically maintain hemoglobin concentrations in patients with CKD, resulting in lower rates of red blood cell transfusion, concerns about cardiovascular safety have lessened the enthusiasm of healthcare providers to prescribe these agents, particularly for patients with NDD-CKD, whose anemia tends
Disclosures
GMC reports grants from NIDDK and Amgen and personal fees from Akebia Therapeutics, Inc., Satellite Healthcare, Ardelyx, AstraZeneca, Baxter, Cricket, DiaMedica, Gilead, Reata, Sanifit, Vertex, Angion, Bayer, and ReCor. PEP reports personal fees from Akebia Therapeutics, Inc., Astra-Zeneca, Bayer, Reata, Gilead, Corvidia, FibroGen, Tricida, and Ardelyx. PEP's institution, Renal Associates (PA), has received support from multiple pharmaceutical companies, including Akebia Therapeutics, Inc. RA
Funding
Akebia Therapeutics, Inc. and Otsuka Pharmaceuticals.
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Cited by (0)
- 1
Was an employee of Akebia Therapeutics, Inc. at the time the trial was conducted.