In my opinion, a cognition or renal trial could start as a Phase 2 or Phase 3 if the inclusion criteria of the patients in these future are similar to the current BETonMACE cognition and renal sub-groups. However, the current renal trial listed on ClinicalTrials.gov is for end stage renal disease (ESRD) patients on dialysis. BETonMACE excludes those with "Evidence of severe renal impairment as determined by either eGFR<30 mL/min/1.7m2 at Visit 1 or current need for dialysis." The sicker the patients and the more the patients' health conditions differ from BETonMACE, the more burden of proof for safety in an early Phase 1/2 trial before going into later Phase 2/3.

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