Efficacy and Safety of Chelation Therapy with Calcium Disodium EDTA (ethylenediaminetetraacetic acid) in the Progression of Chronic Kidney Disease of Unknown Etiology in Sri Lanka

INTERVENTION: Study setting: University Medical Unit at Teaching Hospital, Anuradhapura, Sri Lanka. Participants meeting the inclusion/exclusion criteria will be allocated to the study arms using computer‐generated randomization. Arm 1 (intervention arm): The treatment group will receive an intravenous infusion of 1g calcium disodium EDTA mixed with 200ml 0.9% NaCl over two hours. The administration of the EDTA will be performed under continuous cardiac monitoring and the treatment cycle will be repeated weekly for 3 months (total of 12 cycles). Arm 2 (control arm): The placebo group will receive 20ml of 50% dextrose in 200ml of 0.9% NaCl over two hours. The administration of the placebo will be performed under continuous cardiac monitoring and the treatment cycle will be repeated weekly for 3 months (total of 12 cycles). At the end of the intervention participants will be followed up once in three months for 21 months (24 months total follow up). As the population is patients with early CKD, most patients will not be on any medication. Some will be on ACEI (angiotensin converting enzyme inhibitors). This standard therapy will be continued. Blinding will be as follows Participants ‐ Blinded Healthcare providers ‐ Blinded Data collectors ‐ Blinded Outcome adjudicators ‐ Blinded Data analysts ‐ Blinded CONDITION: Chronic Kidney Disease of Unknown Etiology PRIMARY OUTCOME: Progression of kidney disease as determined by changes in ; 1. Albuminuria ‐ determined by urine albumin‐creatinine ratio (UACR) Kit set; 2. Serum beta 2 microglobulin ; 3. Serum creatinine ; 4. Glomerular Filtration Rate (GFR) – determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) equation; SECONDARY OUTCOME: 1. Rate of decline of GFR ; 2. Reduction of urine Cd level (cadmium, heavy metal) ; 3. Safety outcomes – acute hypersensitivity reactions measured by clinical observation. ; INCLUSION CRITERIA: 1. Males and females aged between 18 and 75 years 2. Stages 1‐3 of chronic kidney disease of unknown origin 3. High cadmium body burden (urinary cadmium levels > 4.94ug per g of creatinine according to WHO/ FAO toxicokinetic model).