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 -

SLCTR Registration Number

SLCTR/2017/026


Date of Registration

25 Aug 2017

The date of last modification

Aug 25, 2017



Application Summary


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 of Health Condition(s) Studied

Chronic Kidney Disease of uncertain etiology (CKD-u)


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1198-9085


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

2017/EC/12 (ERC:Peradeniya)


Trial Details


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


Assignment

Parallel


Purpose

Treatment


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

  1. Males and females, aged 21 to 65 years
  2. eGFR equal or less than 60ml/min/1.73m2 and more than 15 ml/min/1.73m2
  3. Probable and confirmed CKDu according to Ministry of Health, Sri Lanka, guidelines
  4. Not on renal replacement therapy
  5. Not on urate lowering therapy other than Allopurinol
  6. Laboratory results of serum uric acid within the study cut off (>6mg/dl for males , >5 mg/dl for females)

Exclusion criteria

  1. Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [30 mL] of beer, or 1.5 oz [45 mL] of hard liquor)
  2. History or suspicion of drug abuse.
  3. History of autoimmune disease requiring systemic treatment.
  4. Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
  5. History of malignancy within the previous 5 years (with the exception of nonmelanoma/skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
  6. Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
  7. Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg)
  8. Active peptic ulcer disease requiring treatment.
  9. History of xanthinuria, active liver disease, or hepatic dysfunction.
  10. If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
  11. Known hypersensitivity or allergy to allopurinol


Primary outcome(s)

Change in serum creatinine


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

At baseline and then every 3 months for a total of 60 months


Secondary outcome

  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

  2. Inflammation as assessed by ESR (erythrocyte sedimentation rate) and hsCRP (high-sensitivity C-reactive protein).

  3. End-stage renal disease requiring dialysis therapy as determined by commencing of dialysis and kidney transplant

  4. Mortality


Secondary outcome(s) - Time of assessment(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

  2. Inflammation as assessed by ESR (erythrocyte sedimentation rate) and hsCRP (high-sensitivity C-reactive protein).

  3. End-stage renal disease requiring dialysis therapy as determined by commencing of dialysis and kidney transplant

  4. Mortality



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


Recruitment status

Pending


State of ethics review approval

Approved by ERC, University of Peradeniya on 23rd June 2017 (Ref: 2017/EC12)


Funding source

National Research Council Grant No: TO-14-05



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None