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
Phase 3
- Conditions
- Chronic Kidney Disease of Unknown Etiology
- Registration Number
- SLCTR/2018/021
- Lead Sponsor
- niversity of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression of kidney disease as determined by changes in <br>1. Albuminuria - determined by urine albumin-creatinine ratio (UACR) Kit set<br>2. Serum beta 2 microglobulin <br>3. Serum creatinine <br>4. Glomerular Filtration Rate (GFR) – determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation<br> [At baseline, and at the end of 6 weeks, 12 weeks and 24 months after commencement of the intervention.]<br>
- Secondary Outcome Measures
Name Time Method Rate of decline of GFR [At baseline, and then every 12 weeks for a total of 24 weeks.<br>]<br> Reduction of urine Cd level (cadmium, heavy metal) [ At baseline, and then every 12 weeks for a total of 24 weeks.]<br>Safety outcomes – acute hypersensitivity reactions measured by clinical observation. [Assessed at the time of administration.]<br>