Ethics
DISEASES
This study (clinicaltrials.gov number NCT05154591) was approved by the Medical Ethics Committee of Universidad Nacional Autónoma de Nicaragua (UNAN)-León and sponsored by the Ministry of Health of Nicaragua (MINSA). Human subject procedures were in accordance with the UNAN-León requirements and the Helsinki Declarations of 2000. Informed consent was obtained using the standards of MINSA and the World Health Organization including consent to publish in all formats. Under the requirements of MINSA, the design of clinical studies in life-threatening diseases such as CKDu cannot include placebo treatments.