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
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SLCTR Registration Number
SLCTR/2018/021
Date of Registration
The date of last modification
Mar 03, 2019
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 or Health Condition(s) Studied
Chronic Kidney Disease of Unknown Etiology
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1199-7546
Any other number(s) assigned to the trial and issuing authority
EC/16/101 (ERC: Colombo)
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
Study Phase
Phase 3
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
Exclusion criteria
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
Rate of decline of GFR |
[ At baseline, and then every 12 weeks for a total of 24 weeks. ] |
|
2.
Reduction of urine Cd level (cadmium, heavy metal) |
[ At baseline, and then every 12 weeks for a total of 24 weeks. ] |
|
3.
Safety outcomes – acute hypersensitivity reactions measured by clinical observation. |
[ Assessed at the time of administration. ] |
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
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University of Colombo (Grant No: AP/3/2/2016/CG/23)
Regulatory approvals
Status
Approved
Date of Approval
2017-08-28
Approval number
EC-16-101 (Extension on 01.05.2018)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
