Evaluation of the effect of Allopurionol on the progression of Chronic Kidney Disease of Uncertain etiology in Sri Lanka
- Conditions
- Chronic Kidney Disease of uncertain etiology (CKD-u)
- Registration Number
- SLCTR/2017/026
- Lead Sponsor
- ational Research Council, Sri Lanka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up continuing
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum creatinine [At baseline and then every 3 months for a total of 60 months]<br>
- Secondary Outcome Measures
Name Time Method 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]<br>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]<br>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 ]<br>Mortality [At 12,24 and 60 months from the commencement of the intervention ]<br>