The trial will recruit Stage IV-V non-dialyzed CKD patients.
6. Monthly reports will be prepared by the principal investigator that will include the number of patients recruited, stage of follow up for each patient, notification regarding missing patient data and queries from data received.
At the recruit stage, predation as well as competition for resources can have pronounced consequences for spatial patterns.
Conversely, considering drugs studied under the Fleming stopping rules, the DESR was less likely to accept Hnul at the end of stage I, and so to recruit to stage II.
Using the Simon two-stage minimax design, 15 patients were to be recruited into Stage 1 requiring at least two responses before proceeding to the recruitment of an additional 10 patients in Stage 2. Efficacy was to be claimed if six or more responses were observed from the total of 25 patients.
In contrast to the single-stage design which needs recruitment of all participants at the same time, the smaller sample size recruited at stage 1 is a major advantage of this method.
If funded, the partners in the network may recruit early stage and/or postdoc fellows.
In addition, 16 new patients were recruited to stage 3.
