Dose Escalation and Dose De-Escalation Sample Clauses

Dose Escalation and Dose De-Escalation. Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4, unless contraindicated clinically. The investigator should discuss any reason for not dose-escalating at Week 4 with the medical monitor. The investigator may choose to decrease the patient’s dose to one-half of the prior dose (e.g., 10 mg to 5 mg) if clinically indicated. Dose de-escalation can occur more than once, but the minimum dose permitted is 2.5 mg. Reasons for dose de-escalation should be discussed with the medical monitor prior to changing dose. The Week 4 visit is the only study visit when dose escalation is permitted. Patients may have 1 dose de-escalation prior to Week 4. At Week 4, all patients should dose escalate, unless contra- indicated and discussed with the medical monitor. If patients did not dose de-escalate prior to Week 4, then: • If patients dose escalate at Week 4, at most 2 dose de-escalations are permitted after Week 4 • If patients did not dose escalate at Week 4, then only 1 dose de-escalation is permitted after Week 4 If patients did dose de-escalate prior to Week 4, then: • If patients did dose escalate at Week 4, only 1 dose de-escalation is permitted after Week 4 • If patients did not dose escalate at Week 4, then no further dose de-escalations are permitted after Week 4 After Week 4, once a patient’s dose has been reduced, dose escalation back to a higher dose is not permitted. If a patient’s dose was reduced to 2.5 mg prior to the Week 4 visit, they are permitted to escalate to 5 mg at Week 4. Unscheduled visits due to dose de-escalation should include assessments detailed in Section 9.7.