Home » Trials » SLCTR/2018/021


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 -

SLCTR Registration Number

SLCTR/2018/021


Date of Registration

05 Jul 2018

The date of last modification

Jul 06, 2018



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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


Disease of Health Condition(s) Studied

Chronic Kidney Disease of Unknown Etiology


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1199-7546


Any other number(s) assigned to the trial and issuing authority

EC/16/101 (ERC: Colombo)


Trial Details


What is the research question being addressed?

Does EDTA chelation therapy prevent the progression of chronic kidney disease of unknown aetiology?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

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


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


Primary outcome(s)

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


Primary outcome(s) - Time of assessment(s)

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


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.

Secondary outcome(s) - Time of assessment(s)

  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.


Target number/sample size

125 (82 in treatment arm & 43 in placebo arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-09-01


Anticipated end date

2021-08-31


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo on 21st July 2016 extended on 14th October 2017 (Ref. EC/16/101)


Funding source

University of Colombo (Grant No: AP/3/2/2016/CG/23)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Eranga Wijewickrama
Senior Lecturer and Consultant Nephrologist
Department of Clinical Medicine, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
+94112517853
Tel: +94777250214

erangasw@gmail.com

Contact Person for Public Queries

Mr. Priyantha Nawarathne
Research Assistant
Department of Clinical Medicine, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka

Tel: +94771569266

priyantha.cmb.ckdu@gmail.com


Primary study sponsor/organization

University of Colombo

Academic & Publication Branch College House, No 94 Kumarathunga Munidasa Mawatha Colombo 3
Tel: 0112586712
Fax: 0112586712
acpbuoc@gmail.com
http://www.cmb.ac.lk/administration/?page_id=155

Secondary study sponsor (If any)

None