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Despite operational delays, COVID interruptions and Ukraine war outbreak, targets were met.

SITUATION

George Clinical was chosen by a large pharmaceutical company to provide scientific leadership services across all participating countries in an ongoing Phase IIb, randomized, double-blind, placebo-controlled, multicenter study to assess the reduction of albumin in the urine of participants with proteinuric CKD, as well as to determine optimum dosage of the study drug.

The study was conducted in over 100 sites across multiple countries in the Americas, Europe and Asia, and enrolled over 600 adults.

George Clinical’s global kidney and metabolic scientific leadership team has a proven track record in important renal trials with a reputation for maintaining the scientific integrity of the trial, optimizing recruitment and retention, and ensuring cultural alignment.

CHALLENGES

Recruitment and retention of CKD patients is always challenging, as they are severely ill and either on dialysis or trying to avoid going on dialysis. This study required that patients be screened for certain inclusion criteria and, once enrolled, monitored for specific reactions—both of which required a level of precise investigator knowledge.

There were also logistical problems at the outset of the study that delayed screening, created communication issues and could have potentially caused sites to lose focus on the study while waiting for resolution. And once the study was in progress, the sponsor was concerned over a lack of subjects enrolling in the sub study and the low usage of e-diaries, which were key to the success of the study.