Home » Trials » SLCTR/2017/026
Open label randomized controlled clinical trial to study the effects of achieving lowered uric acid targets with Allopurinol on rate of progression, cardiovascular morbidity and inflammatory markers of Chronic Kidney Disease of uncertain etiology (CKD-u) Sri Lanka
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SLCTR Registration Number
SLCTR/2017/026
Date of Registration
The date of last modification
Jul 16, 2020
Trial Status
Scientific Title of Trial
Open label randomized controlled clinical trial to study the effects of achieving lowered uric acid targets with Allopurinol on rate of progression, cardiovascular morbidity and inflammatory markers of Chronic Kidney Disease of uncertain etiology (CKD-u) Sri Lanka
Public Title of Trial
Evaluation of the effect of Allopurionol on the progression of Chronic Kidney Disease of Uncertain etiology in Sri Lanka
Disease or Health Condition(s) Studied
Chronic Kidney Disease of uncertain etiology (CKD-u)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1198-9085
Any other number(s) assigned to the trial and issuing authority
2017/EC/12 (ERC:Peradeniya)
What is the research question being addressed?
Does lowering uric acid targets with Allopurinol reduce the rate of progression, cardiovascular morbidity and inflammatory markers of Chronic Kidney Disease of uncertain etiology (CKD-u) in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
The study will be carried out at the Girandurukotte renal clinic, Sri Lanka. Participants meting inclusion/exclusion criteria will be allocated into the study arms using simple randomization.
The intervention arm will receive Allopurinol 100-600mg, tablet dosage form, oral route, daily dose for a total of 60 months. (Allopurinol starting dose of 100mg daily will be titrated to a maximum dose of 600mg daily until the study targets are achieved.)
Standard management of CKDu will be provided according to the Ministry of Health Guidelines.
The control arm will receive standard management alone (Ministry of Health Guidelines)
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in serum creatinine |
[ At baseline and then every 3 months for a total of 60 months ] |
Secondary outcome(s)
|
1.
Cardiovascular events as measured by changes in systolic blood pressure, diastolic blood pressure, lipid profile and onset of any cardiovascular events like congestive heart failure, Ischemic heart diseases, cerebrovascular diseases, peripheral artery diseases |
[ At 12,24 and 60 months from the commencement of the intervention ] |
|
2.
Inflammation as assessed by ESR (erythrocyte sedimentation rate) and hsCRP (high-sensitivity C-reactive protein). |
[ At 12,24 and 60 months from the commencement of the intervention ] |
|
3.
End-stage renal disease requiring dialysis therapy as determined by commencing of dialysis and kidney transplant |
[ At 12,24 and 60 months from the commencement of the intervention ] |
|
4.
Mortality |
[ At 12,24 and 60 months from the commencement of the intervention ] |
Target number/sample size
500 (250 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-09-01
Anticipated end date
2022-12-20
Date of first enrollment
2017-12-15
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
National Research Council Grant No: TO-14-05
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-06-23
Approval number
2017/EC12
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Nishantha Nanayakkara
Consultant Nephrologist
Nephrology and Dialysis Unit, Teaching Hospital Kandy, Sri Lanka
Mob: +94714964313
nishansrikandy@yahoo.co.in
Contact Person for Public Queries
Thilini Wasana Hettiarachchi
PhD Candidate
Centre for Education, Research and Training on Kidney Diseases, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Mob: +94712284737
hatwasana@gmail.com
Primary study sponsor/organization
National Research Council, Sri Lanka
120/7 Vidya Mawatha, Colombo 7, Sri Lanka
+94112675176
+94112675136
nrc@sltnet.lk
http://www.nrc.gov.lk/
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
