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

Efficacy and safety of chelation therapy with Calcium Disodium EDTA in reducing the progression of Chronic Kidney Disease of unknown etiology in Sri Lanka- A Double blinded placebo controlled randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/021

Enrollment

Unknown

Registered

2018-07-05

Start date

2018-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease of Unknown Etiology

Interventions

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

Eligibility

Inclusion criteria

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).

Exclusion criteria

Exclusion criteria: 1. Patients with acute myocardial infarction or stroke in the previous six months 2. Hypertension 3. Diabetes 4. Patients with cancers 5. Known cardiac arrhythmias 6. Seizures disorders 7. Known hypersensitivity to Calcium Disodium EDTA 8. Hypocalcaemia 9. Pregnancy and breast feeding

Design outcomes

Primary

Measure	Time frame
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 [At baseline, and at the end of 6 weeks, 12 weeks and 24 months after commencement of the intervention.]	—

Measure

Time frame

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 [At baseline, and at the end of 6 weeks, 12 weeks and 24 months after commencement of the intervention.]

—

Secondary

Measure	Time frame
Rate of decline of GFR [At baseline, and then every 12 weeks for a total of 24 weeks. ] Reduction of urine Cd level (cadmium, heavy metal) [ At baseline, and then every 12 weeks for a total of 24 weeks.] Safety outcomes – acute hypersensitivity reactions measured by clinical observation. [Assessed at the time of administration.]	—

Countries

Sri Lanka

Contacts

Public ContactDr. Eranga Wijewickrama

Senior Lecturer and Consultant Nephrologist

erangasw@gmail.com+94112517853

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026