While clinical trial sponsors are continually seeking ways to improve the speed and efficiency of their trials, they often overlook one of the most basic elements that, if done improperly, can quickly derail even their best laid plans: the protocol. This white paper addresses how simplified yet robust protocol design is especially important in renal clinical trials, the success of which depends greatly on thorough consideration of the patient and his or her physical and emotional support system, the investigator’s needs and the external competitive landscape.